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Effect of Single Dose Ketamine and Magnesium on Postoperative Pain in Patients Undergoing Bariatric Surgery

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ClinicalTrials.gov Identifier: NCT02334059
Recruitment Status : Completed
First Posted : January 8, 2015
Results First Posted : November 19, 2019
Last Update Posted : June 1, 2020
Sponsor:
Information provided by (Responsible Party):
Sanjib D Adhikary, Milton S. Hershey Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Obesity
Interventions Drug: Ketamine
Drug: Ketamine plus magnesium
Other: Placebo
Enrollment 108
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ketamine Ketamine Plus Magnesium Placebo
Hide Arm/Group Description

Ketamine: 0.5 mg/kg IV dose

Ketamine: Ketamine infusion plus placebo infusion of normal saline

Placebo: 2 placebo infusions

Ketamine plus magnesium group: 0.5 mg/kg IV dose as well as Magnesium 2 grams IV

Ketamine plus magnesium: Ketamine plus magnesium infusion

Placebo (normal saline)

Placebo: 2 placebo infusions

Period Title: Overall Study
Started 37 34 37
Completed 37 34 37
Not Completed 0 0 0
Arm/Group Title Ketamine Ketamine Plus Magnesium Placebo Total
Hide Arm/Group Description

Ketamine: 0.5 mg/kg IV dose

Ketamine: Ketamine infusion plus placebo infusion of normal saline

Placebo: 2 placebo infusions

Ketamine plus magnesium group: 0.5 mg/kg IV dose as well as Magnesium 2 grams IV

Ketamine plus magnesium: Ketamine plus magnesium infusion

Placebo (normal saline)

Placebo: 2 placebo infusions

Total of all reporting groups
Overall Number of Baseline Participants 37 34 37 108
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 37 participants 34 participants 37 participants 108 participants
43.68  (10.82) 44.15  (11.91) 39.97  (11.60) 42.56  (11.49)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 34 participants 37 participants 108 participants
Female
27
  73.0%
29
  85.3%
29
  78.4%
85
  78.7%
Male
10
  27.0%
5
  14.7%
8
  21.6%
23
  21.3%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 37 participants 34 participants 37 participants 108 participants
37 34 37 108
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 37 participants 34 participants 37 participants 108 participants
47.48  (9.85) 45.57  (6.73) 47.37  (8.70) 46.84  (8.53)
Duration of Surgery  
Mean (Standard Deviation)
Unit of measure:  Minutes
Number Analyzed 37 participants 34 participants 37 participants 108 participants
55.14  (8.25) 67.06  (15.12) 64.78  (13.23) 62.19  (13.39)
Pre-operative Pain Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 37 participants 34 participants 37 participants 108 participants
0.27  (1.04) 0.35  (0.95) 0.41  (1.3) 0.34  (1.1)
[1]
Measure Description: Pain Scores will be determined pre-operatively using the Visual Analogue Scale (VAS). The VAS is a 10 point scale, where 0 = no pain and 10 = worst pain a subject has ever felt.
Pre-operative sedation score   [1] 
Median (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 37 participants 34 participants 37 participants 108 participants
2  (0.0) 1.97  (0.17) 2  (0.16) 2  (0.14)
[1]
Measure Description: Sedation scoring will be determined using the Modified Ramsay Sedation Scale. The Modified Ramsay Sedation Scale is a 6 point scale used to determine alertness, where 1 = patient is awake, anxious, agitated, or restless and 6 = patient with no response to any stimuli (light, noise, or pain). A higher number represents an increased sedative state.
Pre-operative PONV score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 37 participants 34 participants 37 participants 108 participants
0.16  (0.50) 0.03  (0.17) 0.14  (0.54) 0.11  (0.44)
[1]
Measure Description:

The Pre-Operative PONV score will be determined using the PONV Impact Scale. This scale consists of two questions (rated from 0 to 3) for both questions and the sum of the responses are added for a total PONV score.

Question 1 asks if an individual has vomited or had any dry retching, where 0 = Not at all, 1 = Once, 2= Twice, and 3= Three or more times.

Question 2 asks if an individual has experienced a feeling of nausea, where 0 = Not at all, 1 = Sometimes, 2 = Often or most of the time, and 3 = All of the time.

total score (mean and std deviation) is reported and total ranges from 0-3.

1.Primary Outcome
Title Total Hydromorphone Use
Hide Description Total hydromorphone use in 1st 24 hours post-operatively.
Time Frame During surgery and 24 hours post-op
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine Ketamine Plus Magnesium Placebo
Hide Arm/Group Description:

Ketamine: 0.5 mg/kg IV dose

Ketamine: Ketamine infusion plus placebo infusion of normal saline

Placebo: 2 placebo infusions

Ketamine plus magnesium group: 0.5 mg/kg IV dose as well as Magnesium 2 grams IV

Ketamine plus magnesium: Ketamine plus magnesium infusion

Placebo (normal saline)

Placebo: 2 placebo infusions

Overall Number of Participants Analyzed 37 34 37
Mean (95% Confidence Interval)
Unit of Measure: mcg/Kg
Intraoperative
161.5
(119.6 to 203.3)
159.6
(109.4 to 209.7)
195.9
(149.6 to 242.3)
PACU
41.9
(20.5 to 63.3)
47.8
(24.6 to 71.0)
47.3
(24.1 to 70.5)
2.Secondary Outcome
Title Pain Scores Using Verbal Analogue Scale (VAS)
Hide Description Pain scores using VAS scale will be recorded pre-operatively, in the PACU, and every 4 hours until 24 hours post-op. The VAS is a 10 point scale, where 0 = no pain and 10 = the worst pain a subject has ever felt. The highest value 10, indicates an extreme self reported level of pain.
Time Frame Preoperatively and the 1st 24 hours post-op
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ketamine Ketamine Plus Magnesium Placebo
Hide Arm/Group Description:

Ketamine: 0.5 mg/kg IV dose

Ketamine: Ketamine infusion plus placebo infusion of normal saline

Placebo: 2 placebo infusions

Ketamine plus magnesium group: 0.5 mg/kg IV dose as well as Magnesium 2 grams IV

Ketamine plus magnesium: Ketamine plus magnesium infusion

Placebo (normal saline)

Placebo: 2 placebo infusions

Overall Number of Participants Analyzed 37 34 37
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Prior to Surgery
0.41
(-0.03 to 0.84)
0.35
(0.02 to 0.68)
0.27
(-0.08 to 0.62)
PACU
5.78
(4.86 to 6.71)
6.03
(4.86 to 6.78)
5.95
(4.91 to 6.98)
4h after surgery
3.89
(3.20 to 4.57)
4.29
(3.53 to 5.06)
4.65
(4.01 to 5.29)
8h after surgery
3.67
(3.09 to 4.24)
3.75
(2.9 to 4.60)
3.64
(3.08 to 4.20)
12h after surgery
3.16
(2.59 to 3.73)
3.91
(3.28 to 4.53)
2.69
(2.07 to 3.30)
16h after surgery
2.97
(2.3 to 3.64)
3.64
(2.89 to 4.38)
3.09
(2.51 to 3.66)
20h after surgery
3.22
(2.42 to 4.01)
4.13
(3.45 to 4.8)
2.94
(2.36 to 3.53)
24h after surgery
3.24
(2.59 to 3.88)
3.48
(2.81 to 4.15)
3.33
(2.63 to 4.04)
3.Secondary Outcome
Title Intraoperative Minimum Alveolar Concentration (MAC) of Desflurane
Hide Description The average MAC concentration of desflurane will be recorded during the intraoperative period. The Minimum Alveolar Concentration (MAC) of an inhaled anesthetic is the alveolar (or end-expiratory) concentration at which 50% of patients will not show a motor response to a standardized surgical incision.
Time Frame Intraoperative period
Hide Outcome Measure Data
Hide Analysis Population Description
Intraoperative period: Intraoperative Minimum Alveolar Concentration (MAC) of desflurane
Arm/Group Title Ketamine Ketamine Plus Magnesium Placebo
Hide Arm/Group Description:

Ketamine: 0.5 mg/kg IV dose

Ketamine: Ketamine infusion plus placebo infusion of normal saline

Placebo: 2 placebo infusions

Ketamine plus magnesium group: 0.5 mg/kg IV dose as well as Magnesium 2 grams IV

Ketamine plus magnesium: Ketamine plus magnesium infusion

Placebo (normal saline)

Placebo: 2 placebo infusions

Overall Number of Participants Analyzed 37 34 37
Mean (95% Confidence Interval)
Unit of Measure: Minimal Alveolar Concentration (MAC)
4.05
(3.74 to 4.35)
4.02
(3.73 to 4.32)
4.34
(3.98 to 4.71)
Time Frame Perioperative time period (within 24 hours) up to 24 hours post surgery
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ketamine Ketamine Plus Magnesium Placebo
Hide Arm/Group Description

Ketamine: 0.5 mg/kg IV dose

Ketamine: Ketamine infusion plus placebo infusion of normal saline

Placebo: 2 placebo infusions

Ketamine plus magnesium group: 0.5 mg/kg IV dose as well as Magnesium 2 grams IV

Ketamine plus magnesium: Ketamine plus magnesium infusion

Placebo (normal saline)

Placebo: 2 placebo infusions

All-Cause Mortality
Ketamine Ketamine Plus Magnesium Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/37 (0.00%)   0/34 (0.00%)   0/37 (0.00%) 
Hide Serious Adverse Events
Ketamine Ketamine Plus Magnesium Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/37 (0.00%)   0/34 (0.00%)   0/37 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ketamine Ketamine Plus Magnesium Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/37 (0.00%)   0/34 (0.00%)   0/37 (0.00%) 
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: Sanjib D Adhikary
Organization: Penn State Health Anesthesiology and Perioperative Medicine
Phone: 717-531-6597
EMail: sadhikary1@pennstatehealth.psu.edu
Layout table for additonal information
Responsible Party: Sanjib D Adhikary, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT02334059    
Other Study ID Numbers: STUDY00001623
First Submitted: December 23, 2014
First Posted: January 8, 2015
Results First Submitted: July 15, 2019
Results First Posted: November 19, 2019
Last Update Posted: June 1, 2020