A Study Comparing the Use of Deep or Standard Neuromuscular Blockade in Combination With Low or Standard Insufflation Pressures in Participants Undergoing Laparoscopic Cholecystectomy (P07982 AM1) - Full Text View

Purpose

The purpose of this pilot study is to compare the use of deep or standard neuromuscular blockade (NMB) in combination with low or standard insufflation pressure in participants undergoing a surgical procedure, laparoscopic cholecystectomy. Insufflation refers to the injection of carbon dioxide into the abdomen during the laparoscopic surgery, to allow visualization of and access to the surgical field. The primary hypothesis of the study is that the use of sustained deep NMB improves the surgeon's overall satisfaction with surgical conditions as compared to standard NMB. The inpatient surgery is performed on Day 1 and the participant remains hospitalized for at least 48 hours following the surgery. On Day 8, a follow-up visit/contact including all participants occurs.

Condition	Intervention	Phase
Gallbladder Disease	Drug: Rocuronium Other: Insufflation Drug: Sugammadex	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Randomized, Controlled, Parallel-Group, Double-Blind Trial to Compare the Use of Deep or Standard Neuromuscular Blockade in Combination With Low or Standard Insufflation Pressures Using a 2x2 Factorial Design in Patients Undergoing Laparoscopic Cholecystectomy (Protocol No. MK-8616-076-00 Also Known as SCH 900616, P07982)

Resource links provided by NLM:

MedlinePlus related topics: Gallbladder Diseases

Drug Information available for: Rocuronium bromide Rocuronium

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Score on surgeon's rating of overall satisfaction with the surgical conditions [ Time Frame: End of surgery (Day 1) ] [ Designated as safety issue: No ]
At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (poor, needed intervention) to 10 (excellent): "How satisfied were you overall with the surgical conditions related to anesthesia and pneumoperitoneum during the surgery you just performed?"

Secondary Outcome Measures:

Participant's overall reported pain within 24 hours after administration of sugammadex [ Time Frame: Up to 24 hours after administration of sugammadex on Day 1 ] [ Designated as safety issue: Yes ]
Score on surgeon's rating of overall satisfaction with the visibility of the surgical field [ Time Frame: End of surgery (Day 1) ] [ Designated as safety issue: No ]
At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (poor, unacceptable visibility) to 10 (excellent): "How satisfied were you overall with the visual field during the surgery you just performed?"
Score on surgeon's rating of the overall adequacy of muscle relaxation during surgery [ Time Frame: End of surgery (Day 1) ] [ Designated as safety issue: No ]
At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (poor, unacceptable muscle relaxation, required intervention) to 10 (excellent): "How do you rate the overall adequacy of muscle relaxation during the surgery you just performed?"
Score on surgeon's rating of the overall adequacy of insufflation pressure during surgery [ Time Frame: End of surgery (Day 1) ] [ Designated as safety issue: No ]
At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (poor, unacceptable insufflation pressure, required intervention) to 10 (excellent): "How do you rate the overall adequacy of insufflation pressure during the surgery you just performed?"
Number of times participant's movements or increased muscle tone interfered with the surgical conditions during laparoscopy [ Time Frame: During surgery, approximate duration of 1-2 hours (Day 1) ] [ Designated as safety issue: No ]
Score on surgeon's assessment of the effect participant's movements during surgery had on the overall surgical procedure [ Time Frame: End of surgery (Day 1) ] [ Designated as safety issue: No ]
At the end of the procedure the surgeon responds to the following question, using an 11-point scale from 0 (extremely disruptive) to 10 (not disruptive): "How did the patient movements described above disrupt your surgical performance?" This refers to participant movements during surgery.
Number of rescue actions performed during surgery in order to improve insufficient surgical conditions [ Time Frame: During surgery, approximate duration of 1-2 hours (Day 1) ] [ Designated as safety issue: No ]
Daily assessments of participant's reported overall pain [ Time Frame: Days 2 to 8 ] [ Designated as safety issue: Yes ]
Post operative use of analgesic medications [ Time Frame: Up to Day 8 ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	November 2012
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Standard NMB and standard insufflation pressure	Drug: Rocuronium NMB will be induced by intravenous (IV) administration of a bolus dose of 0.45 mg/kg rocuronium. NMB will be maintained using rocuronium infusion or additional bolus doses as needed for the management of NMB to the targeted depth according to the assigned treatment condition. Standard NMB - administration of neuromuscular blocking agent (NMBA) titrated to a depth of blockade at a targeted Train of Four (TOF) ratio of 10% (range: TOF count 2-3 to TOF ratio of 20%). Deep NMB - administration of NMBA titrated to a targeted depth of 1-2 Post Tetanic Counts (PTCs) (range: 1-5 PTC). Other Name: Zemuron® Injection (rocuronium bromide) Other: Insufflation Insufflation (injection) of carbon dioxide will be used to induce pneumoperitoneum, which is presence of air or gas in the abdominal (peritoneal) cavity. Standard insufflation pressure - a starting pressure of 12 mmHg will be used. Low insufflation pressure - a starting pressure of 8 mmHg will be used. Drug: Sugammadex NMB will be reversed with IV administration of 2 or 4 mg/kg sugammadex (depending on the depth of NMB) according to the approved label for sugammadex. Other Names: sugammadex sodium injection SCH 900916 Org 25969 Bridion®
Experimental: Standard NMB and low insufflation pressure	Drug: Rocuronium NMB will be induced by intravenous (IV) administration of a bolus dose of 0.45 mg/kg rocuronium. NMB will be maintained using rocuronium infusion or additional bolus doses as needed for the management of NMB to the targeted depth according to the assigned treatment condition. Standard NMB - administration of neuromuscular blocking agent (NMBA) titrated to a depth of blockade at a targeted Train of Four (TOF) ratio of 10% (range: TOF count 2-3 to TOF ratio of 20%). Deep NMB - administration of NMBA titrated to a targeted depth of 1-2 Post Tetanic Counts (PTCs) (range: 1-5 PTC). Other Name: Zemuron® Injection (rocuronium bromide) Other: Insufflation Insufflation (injection) of carbon dioxide will be used to induce pneumoperitoneum, which is presence of air or gas in the abdominal (peritoneal) cavity. Standard insufflation pressure - a starting pressure of 12 mmHg will be used. Low insufflation pressure - a starting pressure of 8 mmHg will be used. Drug: Sugammadex NMB will be reversed with IV administration of 2 or 4 mg/kg sugammadex (depending on the depth of NMB) according to the approved label for sugammadex. Other Names: sugammadex sodium injection SCH 900916 Org 25969 Bridion®
Experimental: Deep NMB and standard insufflation pressure	Drug: Rocuronium NMB will be induced by intravenous (IV) administration of a bolus dose of 0.45 mg/kg rocuronium. NMB will be maintained using rocuronium infusion or additional bolus doses as needed for the management of NMB to the targeted depth according to the assigned treatment condition. Standard NMB - administration of neuromuscular blocking agent (NMBA) titrated to a depth of blockade at a targeted Train of Four (TOF) ratio of 10% (range: TOF count 2-3 to TOF ratio of 20%). Deep NMB - administration of NMBA titrated to a targeted depth of 1-2 Post Tetanic Counts (PTCs) (range: 1-5 PTC). Other Name: Zemuron® Injection (rocuronium bromide) Other: Insufflation Insufflation (injection) of carbon dioxide will be used to induce pneumoperitoneum, which is presence of air or gas in the abdominal (peritoneal) cavity. Standard insufflation pressure - a starting pressure of 12 mmHg will be used. Low insufflation pressure - a starting pressure of 8 mmHg will be used. Drug: Sugammadex NMB will be reversed with IV administration of 2 or 4 mg/kg sugammadex (depending on the depth of NMB) according to the approved label for sugammadex. Other Names: sugammadex sodium injection SCH 900916 Org 25969 Bridion®
Experimental: Deep NMB and low insufflation pressure	Drug: Rocuronium NMB will be induced by intravenous (IV) administration of a bolus dose of 0.45 mg/kg rocuronium. NMB will be maintained using rocuronium infusion or additional bolus doses as needed for the management of NMB to the targeted depth according to the assigned treatment condition. Standard NMB - administration of neuromuscular blocking agent (NMBA) titrated to a depth of blockade at a targeted Train of Four (TOF) ratio of 10% (range: TOF count 2-3 to TOF ratio of 20%). Deep NMB - administration of NMBA titrated to a targeted depth of 1-2 Post Tetanic Counts (PTCs) (range: 1-5 PTC). Other Name: Zemuron® Injection (rocuronium bromide) Other: Insufflation Insufflation (injection) of carbon dioxide will be used to induce pneumoperitoneum, which is presence of air or gas in the abdominal (peritoneal) cavity. Standard insufflation pressure - a starting pressure of 12 mmHg will be used. Low insufflation pressure - a starting pressure of 8 mmHg will be used. Drug: Sugammadex NMB will be reversed with IV administration of 2 or 4 mg/kg sugammadex (depending on the depth of NMB) according to the approved label for sugammadex. Other Names: sugammadex sodium injection SCH 900916 Org 25969 Bridion®

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Scheduled to undergo an elective in-patient laparoscopic cholecystectomy procedure under general anesthesia with total intravenous anesthesia (TIVA) using propofol and remifentanil
Eligible to undergo rocuronium-induced NMB for endotracheal intubation and maintenance of NMB
Will recover in the post-anesthesia care unit (PACU) and remain in the hospital for at least 48 hours following the surgical procedure
Body mass index (BMI) ≤35
Willing and able to adhere to visit schedules including all required study assessments on Day 3 through 8 (daily pain and medication diary entry)
For sexually active female participants of child-bearing potential - able to use a medically accepted method of contraception through 7 days after receiving protocol-specified medication

Exclusion criteria:

Neuromuscular disorders that may affect NMB and/or trial assessments
History of previous laparoscopy procedures including laparoscopic hernia repairs and laparotomies (but not a diagnostic laparoscopy)
Substance abuse or dependence (excluding nicotine) within the past 6 months
History of a chronic pain condition
For female participants - previously has given birth to one or more children
For female participants of childbearing potential - is pregnant or has the intention to become pregnant between randomization and pregnancy follow-up contact ≥30 days after administration of trial treatments (rocuronium or sugammadex)
Evidence of acute cholecystitis
Dialysis-dependency or suspected of having severe renal insufficiency
Significant hepatic dysfunction that would prevent participation in the trial
History of or family history of malignant hyperthermia
Allergy to trial treatments (rocuronium or sugammadex) or their excipients, to opioids/opiates, or other medication used during general anesthesia
Received or is planned to receive toremifene or fusidic acid within 24 hours before or after receiving rocuronium or sugammadex
Expected transfer to an Intensive Care Unit after surgery
Any clinically significant condition or situation, other than the reason for the cholecystectomy that would interfere with the trial evaluations or optimal participation in the trial
Used any investigational drugs within 30 days of randomization
Participated in any other clinical trial within 30 days of signing the informed consent form of the current trial
Participated in any other clinical trial involving any personnel of the investigational or Sponsor staff directly involved with this trial
Is a family member of any personnel of the investigational or Sponsor staff directly involved with this trial

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01728584

Contacts

Contact: Toll Free Number

1-888-577-8839

Locations

Austria
MSD Osterreich GmbH	Recruiting
Vienna, Austria
Contact: Karl Boegl 43 126044130
Finland
MSD Finland Oy	Recruiting
Espoo, Finland
Contact: Kaisa Elomaa 358 20 7570300
Germany
Merck Sharp & Dohme GmbH	Recruiting
Haar, Germany
Contact: Kristian Lobner 49 89 4561 1102
Italy
MSD Italia S.r.l.	Recruiting
Rome, Italy
Contact: Patrizia Nardini 39 06 361911
United Kingdom
Merck Sharp & Dohme Ltd.	Recruiting
Hoddesdon, United Kingdom
Contact: Paul Robinson 44 1992452396

Sponsors and Collaborators

Merck

More Information

No publications provided

Responsible Party:	Merck
ClinicalTrials.gov Identifier:	NCT01728584 History of Changes
Other Study ID Numbers:	P07982, MK-8616-076, 2012-001886-33
Study First Received:	October 16, 2012
Last Updated:	May 3, 2013
Health Authority:	European Union: European Medicines Agency

Additional relevant MeSH terms:

Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases
Rocuronium
Neuromuscular Nondepolarizing Agents

Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013