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Trial record 4 of 38 for:    "Spinal Disease" | "Benzocaine"

Effect of Neuromuscular Blockade on Operating Conditions and Overall Satisfaction During Spinal Surgery

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ClinicalTrials.gov Identifier: NCT02724111
Recruitment Status : Completed
First Posted : March 31, 2016
Results First Posted : October 13, 2017
Last Update Posted : October 13, 2017
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Byung Gun Lim, Korea University Guro Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Supportive Care
Conditions Neuromuscular Blockade
Surgery
Anesthesia
Spinal Diseases
Interventions Drug: sufficient dose of rocuronium
Drug: sugammadex 10 min after position change
Enrollment 90
Recruitment Details This study was a single-site study recruited and performed at Korea University Guro Hospital, a general hospital, Seoul, South Korea, from 15 May 2016 to 16 February 2017.
Pre-assignment Details No enrolled participants were excluded from the study before assignment to arms or groups.
Arm/Group Title Deep Neuromuscular Blockade Restricted Neuromuscular Blockade
Hide Arm/Group Description

This arm will be given sufficient dose of rocuronium. In this Arm group, rocuronium will be administered to maintain deep neuromuscular blockade [NMB] (train-of-four [TOF] count 0, post-tetanic count [PTC] of 1-2 twitches) until the end of surgery and the reversal of NMB will be performed by sugammadex 4 mg/kg at the end of surgery'.

sufficient dose of rocuronium

This arm will be given restricted (not sufficient) dose of rocuronium. In this Arm group, sugammadex will be administered according to the prescribing indications (4 mg/kg for deep neuromuscular blockade [NMB] state or 2 mg/kg for moderate NMB or less) to reverse the NMB 10 min after position change (sugammadex 10 min after position change [a prone position]). Thereafter, muscle relaxants will not be injected any more throughout the surgery except the following situations: If the patients show any body movement during surgery or if surgeons express any complaint about muscle tone (the muscle tone: grade 3), rescue rocuronium 5 mg will be administered and the number of body movements and rescue rocuronium administration (dose) will be recorded.

sugammadex 10 min after position change

Period Title: Overall Study
Started 45 45
Completed 43 40
Not Completed 2 5
Reason Not Completed
Protocol Violation             2             5
Arm/Group Title Deep Neuromuscular Blockade Restricted Neuromuscular Blockade Total
Hide Arm/Group Description

This arm will be given sufficient dose of rocuronium. In this Arm group, rocuronium will be administered to maintain deep neuromuscular blockade [NMB] (TOF count 0, post-tetanic count [PTC] of 1-2 twitches) until the end of surgery and the reversal of NMB will be performed by sugammadex 4 mg/kg at the end of surgery'.

sufficient dose of rocuronium

This arm will be given restricted (not sufficient) dose of rocuronium. In this Arm group, sugammadex will be administered according to the prescribing indications (4 mg/kg for deep neuromuscular blockade [NMB] state or 2 mg/kg for moderate NMB or less) to reverse the NMB 10 min after position change (sugammadex 10 min after position change [a prone position]). Thereafter, muscle relaxants will not be injected any more throughout the surgery except the following situations: If the patients show any body movement during surgery or if surgeons express any complaint about muscle tone (the muscle tone: grade 3), rescue rocuronium 5 mg will be administered and the number of body movements and rescue rocuronium administration (dose) will be recorded.

sugammadex 10 min after position change

Total of all reporting groups
Overall Number of Baseline Participants 43 40 83
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 40 participants 83 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
30
  69.8%
31
  77.5%
61
  73.5%
>=65 years
13
  30.2%
9
  22.5%
22
  26.5%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 43 participants 40 participants 83 participants
61
(37 to 75)
60
(30 to 75)
60
(30 to 75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 40 participants 83 participants
Female
31
  72.1%
29
  72.5%
60
  72.3%
Male
12
  27.9%
11
  27.5%
23
  27.7%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Korean Number Analyzed 43 participants 40 participants 83 participants
43
 100.0%
40
 100.0%
83
 100.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
South Korea Number Analyzed 43 participants 40 participants 83 participants
43
 100.0%
40
 100.0%
83
 100.0%
Height (m)  
Mean (Standard Deviation)
Unit of measure:  Meter
Number Analyzed 43 participants 40 participants 83 participants
1.59  (0.07) 1.58  (0.08) 1.59  (0.07)
Weight (kg)  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 43 participants 40 participants 83 participants
59.8  (8.5) 60  (6.9) 59.9  (7.7)
1.Primary Outcome
Title Mean Value of Peak Inspiratory Pressure
Hide Description This outcome is the mean value of the peak inspiratory pressure measured at each 15 minute during the anesthesia, which can reflect the degree of the tone of respiratory muscles. As muscle tone increases, airway pressure usually increases due to increased tone of abdominal muscle and respiratory muscles including diaphragm. The longer the surgery goes, the higher the airway pressure gets. Also, as neurospinal surgeries are operated in the prone position, the potential for increased airway pressure is high. As airway pressure gets higher, intrathoracic pressure and intraabdominal pressure also become higher. These consequences may bring about similar results with detrimental effects derived from marked increase in intraabdominal pressure in laparoscopic abdominal surgeries
Time Frame Every 15 minutes during anesthesia, up to 3 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Deep Neuromuscular Blockade Restricted Neuromuscular Blockade
Hide Arm/Group Description:

This arm will be given sufficient dose of rocuronium. In this Arm group, rocuronium will be administered to maintain deep neuromuscular blockade [NMB] (TOF count 0, post-tetanic count [PTC] of 1-2 twitches) until the end of surgery and the reversal of NMB will be performed by sugammadex 4 mg/kg at the end of surgery'.

sufficient dose of rocuronium

This arm will be given restricted (not sufficient) dose of rocuronium. In this Arm group, sugammadex will be administered according to the prescribing indications (4 mg/kg for deep neuromuscular blockade [NMB] state or 2 mg/kg for moderate NMB or less) to reverse the NMB 10 min after position change (sugammadex 10 min after position change [a prone position]). Thereafter, muscle relaxants will not be injected any more throughout the surgery except the following situations: If the patients show any body movement during surgery or if surgeons express any complaint about muscle tone (the muscle tone: grade 3), rescue rocuronium 5 mg will be administered and the number of body movements and rescue rocuronium administration (dose) will be recorded.

sugammadex 10 min after position change

Overall Number of Participants Analyzed 43 40
Mean (Standard Deviation)
Unit of Measure: cmH2O
18.4  (1.1) 20.2  (1.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Deep Neuromuscular Blockade, Restricted Neuromuscular Blockade
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Mean Value of Pressure of Back Muscle Retractor
Hide Description Mean value of pressure of back muscle retractor placed in the operating site (recorded every 15 minutes during the placement of the retractor): measured by the pressure probe placed between the retractor and the back muscle.
Time Frame Every 15 minutes at the period of the retractor placement during surgery, up to 2 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Deep Neuromuscular Blockade Restricted Neuromuscular Blockade
Hide Arm/Group Description:

This arm will be given sufficient dose of rocuronium. In this Arm group, rocuronium will be administered to maintain deep neuromuscular blockade [NMB] (TOF count 0, post-tetanic count [PTC] of 1-2 twitches) until the end of surgery and the reversal of NMB will be performed by sugammadex 4 mg/kg at the end of surgery'.

sufficient dose of rocuronium

This arm will be given restricted (not sufficient) dose of rocuronium. In this Arm group, sugammadex will be administered according to the prescribing indications (4 mg/kg for deep neuromuscular blockade [NMB] state or 2 mg/kg for moderate NMB or less) to reverse the NMB 10 min after position change (sugammadex 10 min after position change [a prone position]). Thereafter, muscle relaxants will not be injected any more throughout the surgery except the following situations: If the patients show any body movement during surgery or if surgeons express any complaint about muscle tone (the muscle tone: grade 3), rescue rocuronium 5 mg will be administered and the number of body movements and rescue rocuronium administration (dose) will be recorded.

sugammadex 10 min after position change

Overall Number of Participants Analyzed 43 40
Mean (Standard Deviation)
Unit of Measure: mmHg
81.2  (9.1) 100  (7.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Deep Neuromuscular Blockade, Restricted Neuromuscular Blockade
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Overall Satisfaction of Surgeons for the Surgical Condition
Hide Description Overall satisfaction of surgeons for the surgical condition will be assessed by the surgeons who perform surgery using numerical rating scale (NRS; 1-10) after surgery (1, worst; 10, best).
Time Frame After surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Deep Neuromuscular Blockade Restricted Neuromuscular Blockade
Hide Arm/Group Description:

This arm will be given sufficient dose of rocuronium. In this Arm group, rocuronium will be administered to maintain deep neuromuscular blockade [NMB] (TOF count 0, post-tetanic count [PTC] of 1-2 twitches) until the end of surgery and the reversal of NMB will be performed by sugammadex 4 mg/kg at the end of surgery'.

sufficient dose of rocuronium

This arm will be given restricted (not sufficient) dose of rocuronium. In this Arm group, sugammadex will be administered according to the prescribing indications (4 mg/kg for deep neuromuscular blockade [NMB] state or 2 mg/kg for moderate NMB or less) to reverse the NMB 10 min after position change (sugammadex 10 min after position change [a prone position]). Thereafter, muscle relaxants will not be injected any more throughout the surgery except the following situations: If the patients show any body movement during surgery or if surgeons express any complaint about muscle tone (the muscle tone: grade 3), rescue rocuronium 5 mg will be administered and the number of body movements and rescue rocuronium administration (dose) will be recorded.

sugammadex 10 min after position change

Overall Number of Participants Analyzed 43 40
Mean (Standard Deviation)
Unit of Measure: Scores on a scale (NRS; 1-10)
8  (1.3) 3.1  (1.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Deep Neuromuscular Blockade, Restricted Neuromuscular Blockade
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title The Muscle Tone
Hide Description The muscle tone of each patient at the screw insertion through the pedicle of spine during surgery scaled by surgeons (1: muscle tone is good, suitable for surgery; 2: muscle tone is moderate, but do not affect the operation; 3: muscle tone is hard, making the operation difficult.).
Time Frame at the screw insertion through the pedicle of spine during surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Deep Neuromuscular Blockade Restricted Neuromuscular Blockade
Hide Arm/Group Description:

This arm will be given sufficient dose of rocuronium. In this Arm group, rocuronium will be administered to maintain deep neuromuscular blockade [NMB] (TOF count 0, post-tetanic count [PTC] of 1-2 twitches) until the end of surgery and the reversal of NMB will be performed by sugammadex 4 mg/kg at the end of surgery'.

sufficient dose of rocuronium

This arm will be given restricted (not sufficient) dose of rocuronium. In this Arm group, sugammadex will be administered according to the prescribing indications (4 mg/kg for deep neuromuscular blockade [NMB] state or 2 mg/kg for moderate NMB or less) to reverse the NMB 10 min after position change (sugammadex 10 min after position change [a prone position]). Thereafter, muscle relaxants will not be injected any more throughout the surgery except the following situations: If the patients show any body movement during surgery or if surgeons express any complaint about muscle tone (the muscle tone: grade 3), rescue rocuronium 5 mg will be administered and the number of body movements and rescue rocuronium administration (dose) will be recorded.

sugammadex 10 min after position change

Overall Number of Participants Analyzed 43 40
Mean (Standard Deviation)
Unit of Measure: Scores on a scale (NRS; 1-3)
1.3  (0.7) 2.5  (0.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Deep Neuromuscular Blockade, Restricted Neuromuscular Blockade
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
5.Secondary Outcome
Title The Number of Body Movements
Hide Description The number of body movements (including cough or any diaphragm movement) observed during the surgery.
Time Frame At the occurrence of the event during surgery, up to 3 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Deep Neuromuscular Blockade Restricted Neuromuscular Blockade
Hide Arm/Group Description:

This arm will be given sufficient dose of rocuronium. In this Arm group, rocuronium will be administered to maintain deep neuromuscular blockade [NMB] (TOF count 0, post-tetanic count [PTC] of 1-2 twitches) until the end of surgery and the reversal of NMB will be performed by sugammadex 4 mg/kg at the end of surgery'.

sufficient dose of rocuronium

This arm will be given restricted (not sufficient) dose of rocuronium. In this Arm group, sugammadex will be administered according to the prescribing indications (4 mg/kg for deep neuromuscular blockade [NMB] state or 2 mg/kg for moderate NMB or less) to reverse the NMB 10 min after position change (sugammadex 10 min after position change [a prone position]). Thereafter, muscle relaxants will not be injected any more throughout the surgery except the following situations: If the patients show any body movement during surgery or if surgeons express any complaint about muscle tone (the muscle tone: grade 3), rescue rocuronium 5 mg will be administered and the number of body movements and rescue rocuronium administration (dose) will be recorded.

sugammadex 10 min after position change

Overall Number of Participants Analyzed 43 40
Mean (Standard Deviation)
Unit of Measure: number of event
0  (0) 2  (1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Deep Neuromuscular Blockade, Restricted Neuromuscular Blockade
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
6.Secondary Outcome
Title The Degree of Bleeding
Hide Description 2.The degree of bleeding of each patient scaled by surgeons (Intraoperative scale for assessment of operating condition of surgical field: 0 - No bleeding, 1 - Slight bleeding - no suctioning of blood required, 2 - Slight bleeding - occasional suctioning required but not threatened the operative field, 3 ‑ Slight‑bleeding - frequent suctioning of blood was required that threatens the operative field a few seconds after suctioning, 4 - Moderate bleeding - frequent suctioning of blood was required which threatens the operative field directly after suctioning, 5 - Severe bleeding - continuous suctioning of blood was required which severely threatened the operative field make the surgery not possible).
Time Frame Continuously observed during the whole period of surgery, up to 3 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Deep Neuromuscular Blockade Restricted Neuromuscular Blockade
Hide Arm/Group Description:

This arm will be given sufficient dose of rocuronium. In this Arm group, rocuronium will be administered to maintain deep neuromuscular blockade [NMB] (TOF count 0, post-tetanic count [PTC] of 1-2 twitches) until the end of surgery and the reversal of NMB will be performed by sugammadex 4 mg/kg at the end of surgery'.

sufficient dose of rocuronium

This arm will be given restricted (not sufficient) dose of rocuronium. In this Arm group, sugammadex will be administered according to the prescribing indications (4 mg/kg for deep neuromuscular blockade [NMB] state or 2 mg/kg for moderate NMB or less) to reverse the NMB 10 min after position change (sugammadex 10 min after position change [a prone position]). Thereafter, muscle relaxants will not be injected any more throughout the surgery except the following situations: If the patients show any body movement during surgery or if surgeons express any complaint about muscle tone (the muscle tone: grade 3), rescue rocuronium 5 mg will be administered and the number of body movements and rescue rocuronium administration (dose) will be recorded.

sugammadex 10 min after position change

Overall Number of Participants Analyzed 43 40
Mean (Standard Deviation)
Unit of Measure: Scores on a scale (NRS; 0-5)
1.8  (0.7) 3.3  (0.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Deep Neuromuscular Blockade, Restricted Neuromuscular Blockade
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
7.Secondary Outcome
Title Recovery Time (Time to Reach Sedation Score 5 at Postanesthesia Care Unit (PACU).
Hide Description the time to reach sedation score 5 (the Observer's Assessment of Alertness/ Sedation (OAA/S) score; awake, 5 to unresponsive, 1) at PACU
Time Frame every 10 min for 1 hour at PACU.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Deep Neuromuscular Blockade Restricted Neuromuscular Blockade
Hide Arm/Group Description:

This arm will be given sufficient dose of rocuronium. In this Arm group, rocuronium will be administered to maintain deep neuromuscular blockade [NMB] (TOF count 0, post-tetanic count [PTC] of 1-2 twitches) until the end of surgery and the reversal of NMB will be performed by sugammadex 4 mg/kg at the end of surgery'.

sufficient dose of rocuronium

This arm will be given restricted (not sufficient) dose of rocuronium. In this Arm group, sugammadex will be administered according to the prescribing indications (4 mg/kg for deep neuromuscular blockade [NMB] state or 2 mg/kg for moderate NMB or less) to reverse the NMB 10 min after position change (sugammadex 10 min after position change [a prone position]). Thereafter, muscle relaxants will not be injected any more throughout the surgery except the following situations: If the patients show any body movement during surgery or if surgeons express any complaint about muscle tone (the muscle tone: grade 3), rescue rocuronium 5 mg will be administered and the number of body movements and rescue rocuronium administration (dose) will be recorded.

sugammadex 10 min after position change

Overall Number of Participants Analyzed 43 40
Mean (Standard Deviation)
Unit of Measure: minute
10.5  (7.9) 17  (11.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Deep Neuromuscular Blockade, Restricted Neuromuscular Blockade
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
8.Secondary Outcome
Title Adverse Events : The Postoperative Nausea and Vomiting Occurrence in Subject
Hide Description The occurrence of any adverse events was recorded in the post-anesthesia care unit (PACU) and a ward during the postoperative 24 hours.
Time Frame during the postoperative 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Deep Neuromuscular Blockade Restricted Neuromuscular Blockade
Hide Arm/Group Description:

This arm will be given sufficient dose of rocuronium. In this Arm group, rocuronium will be administered to maintain deep neuromuscular blockade [NMB] (TOF count 0, post-tetanic count [PTC] of 1-2 twitches) until the end of surgery and the reversal of NMB will be performed by sugammadex 4 mg/kg at the end of surgery'.

sufficient dose of rocuronium

This arm will be given restricted (not sufficient) dose of rocuronium. In this Arm group, sugammadex will be administered according to the prescribing indications (4 mg/kg for deep neuromuscular blockade [NMB] state or 2 mg/kg for moderate NMB or less) to reverse the NMB 10 min after position change (sugammadex 10 min after position change [a prone position]). Thereafter, muscle relaxants will not be injected any more throughout the surgery except the following situations: If the patients show any body movement during surgery or if surgeons express any complaint about muscle tone (the muscle tone: grade 3), rescue rocuronium 5 mg will be administered and the number of body movements and rescue rocuronium administration (dose) will be recorded.

sugammadex 10 min after position change

Overall Number of Participants Analyzed 43 40
Measure Type: Count of Participants
Unit of Measure: Participants
11
  25.6%
8
  20.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Deep Neuromuscular Blockade, Restricted Neuromuscular Blockade
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.202
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame during the postoperative 24 hours
Adverse Event Reporting Description Same.
 
Arm/Group Title Deep Neuromuscular Blockade Restricted Neuromuscular Blockade
Hide Arm/Group Description

This arm will be given sufficient dose of rocuronium. In this Arm group, rocuronium will be administered to maintain deep neuromuscular blockade [NMB] (TOF count 0, post-tetanic count [PTC] of 1-2 twitches) until the end of surgery and the reversal of NMB will be performed by sugammadex 4 mg/kg at the end of surgery'.

sufficient dose of rocuronium

This arm will be given restricted (not sufficient) dose of rocuronium. In this Arm group, sugammadex will be administered according to the prescribing indications (4 mg/kg for deep neuromuscular blockade [NMB] state or 2 mg/kg for moderate NMB or less) to reverse the NMB 10 min after position change (sugammadex 10 min after position change [a prone position]). Thereafter, muscle relaxants will not be injected any more throughout the surgery except the following situations: If the patients show any body movement during surgery or if surgeons express any complaint about muscle tone (the muscle tone: grade 3), rescue rocuronium 5 mg will be administered and the number of body movements and rescue rocuronium administration (dose) will be recorded.

sugammadex 10 min after position change

All-Cause Mortality
Deep Neuromuscular Blockade Restricted Neuromuscular Blockade
Affected / at Risk (%) Affected / at Risk (%)
Total   0/43 (0.00%)   0/40 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Deep Neuromuscular Blockade Restricted Neuromuscular Blockade
Affected / at Risk (%) Affected / at Risk (%)
Total   0/43 (0.00%)   0/40 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Deep Neuromuscular Blockade Restricted Neuromuscular Blockade
Affected / at Risk (%) Affected / at Risk (%)
Total   11/43 (25.58%)   8/40 (20.00%) 
Gastrointestinal disorders     
nausea or vomiting * [1]  11/43 (25.58%)  8/40 (20.00%) 
*
Indicates events were collected by non-systematic assessment
[1]
This adverse event is the postoperative nausea and vomiting occurred during the postoperative 24 hours. The symptoms were all resolved well after administration of antiemetics.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Byung Gun Lim
Organization: Korea University Guro Hospital
Phone: 82-2-2626-1437
EMail: bglim9205@korea.ac.kr
Layout table for additonal information
Responsible Party: Byung Gun Lim, Korea University Guro Hospital
ClinicalTrials.gov Identifier: NCT02724111     History of Changes
Other Study ID Numbers: KUGH15297-002
First Submitted: March 24, 2016
First Posted: March 31, 2016
Results First Submitted: June 9, 2017
Results First Posted: October 13, 2017
Last Update Posted: October 13, 2017