Rocuronium + Sugammadex vs. Succinylcholine + Cisatracurium + Neostigmine/Atropine in Obese Participants (MK-8616-104)

NCT ID: NCT02410590

Last Updated: 2015-07-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2016-10-31

Brief Summary

The primary objective of this trial is to compare the preference between two strategies of neuromuscular blocking (NMB) / reversal in adult obese patients undergoing laparoscopic abdominal surgery: Rocuronium + Sugammadex versus Succinylcholine + Cisatracurium + Neostigmine/Atropine. This will be done evaluating the average verbal numerical scale (VNS) scores obtained from surgeons blinded to the drugs administered. The primary hypothesis is that the strategy "Rocuronium + Sugammadex" provides a better surgical visual field in obese participants undergoing laparoscopic abdominal surgery than the strategy "Succinylcholine + Cisatracurium + Neostigmine/Atropine" as measured by VNS scores.

Conditions

Neuromuscular Blockade

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: DOUBLE

Study Groups

Rocuronium + Sugammadex

Participants will receive rocuronium administered at a dosage adequate to make intubation possible and provide deep NMB (defined as no response to train-of-four stimulation but at least one response to five post-tetanic count \[PTC\]) for the duration of surgery, until the end of the procedure. Sugammadex will be administered to participants once at a dosage of 4 mg/kg real body weight (RBW) IV at the end of surgical procedure. Sugammadex will be used as the only reversal drug in all participants who receive rocuronium as a neuromuscular blocker.

Group Type: EXPERIMENTAL

Rocuronium

Intervention Type: DRUG

Sugammadex

Intervention Type: DRUG

Succinylcholine + Cisatracurium + Neostigmine/Atropine

After receiving succinylcholine 1.0 mg/kg RBW for intubation, participants will receive cisatracurium administered at dosage adequate to have a moderate NMB (defined as a target of TOF ratio = 10% with a range: 2-3 twitches to TOF ratio of 20%) for the duration of surgery, until the end of the procedure. Neostigmine/Atropine will be administered to participants once at respective dosage of 0.05 mg/kg RBW and 0.01 mg/kg RBW at least after the reappearance of T2 after surgery completion. The maximum allowed dosage for Neostigmine is 5 mg. Neostigmine will be used as only reversal drug in all participants who received Cisatracurium as neuromuscular blocker.

Group Type: ACTIVE_COMPARATOR

Cisatracurium

Intervention Type: DRUG

Neostigmine/Atropine

Intervention Type: DRUG

Succinylcholine

Intervention Type: DRUG

Interventions

Rocuronium

Intervention Type: DRUG

Sugammadex

Intervention Type: DRUG

Cisatracurium

Intervention Type: DRUG

Neostigmine/Atropine

Intervention Type: DRUG

Succinylcholine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• must be obese, with a Body Mass Index ≥30.0 to ≤50.
• must be scheduled to undergo an elective abdominal laparoscopic surgery, under general anesthesia. (Participants are expected to remain in the hospital for at least 24 hours following surgical procedure.)
• must be categorized as American Society of Anesthesiologists (ASA) Class 1, 2, or 3.
• clinical laboratory tests within normal limits or clinically acceptable to the investigator/sponsor.
• sexually active females of child-bearing potential must agree to use a medically accepted method of contraception while receiving protocol-specified medication and for the 30 days after stopping the medication. Medically accepted methods of contraception include condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed IUD, inert or copper-containing IUD, hormone-releasing IUD, systemic hormonal contraceptive, and surgical sterilization (eg, hysterectomy or tubal ligation). Postmenopausal women are not required to use contraception. Postmenopausal is defined as at least 12 consecutive months without a spontaneous menstrual period. Each sexually active male subject with a female partner(s) of childbearing potential must also provide written informed consent to provide information regarding any pregnancy.

Exclusion Criteria

• has anatomical malformations that may lead to difficult intubation.
• is known or suspected to have neuromuscular disorders that may affect NMB and/or trial assessments.
• history of previous abdominal laparoscopy procedures.
• must not currently (within past 6 months) meet DSM-IV-TR criteria for substance abuse or dependence (excluding nicotine).
• history of a chronic pain condition (requiring continuous/daily pain medication prior to surgery).
• females who have given birth to one or more children in the last 12 months, or are pregnant or intend to become pregnant between randomization and >Day 30 pregnancy follow-up contact [premenopausal female of childbearing potential].
• evidence of acute cholecystitis.
• dialysis-dependency or suspected of having severe renal insufficiency (defined as estimated creatinine clearance of <30 mL/min).
• significant hepatic dysfunction that would prevent participation in the trial, based on the summary of product characteristics of the study drugs.
• history of or family history of malignant hyperthermia.
• known allergy to trial treatments (rocuronium, sugammadex, succinylcholine, cisatracurium, neostigmine, atropine) or their excipients, to opioids/opiates, or other medication used during general anesthesia.
• expected transfer to intensive care unit after surgery.
• must continue to receive toremifene or fusidic acid during the trial.
• has participated in another clinical trial within 30 days of signing the informed consent form of the current trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

2013-004423-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

8616-104

Identifier Type: -

Identifier Source: org_study_id