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

Neuromuscular Blockade Clinical Trial

— BENN  

Official title:

Randomized, Parallel Group, Controlled Trial to Compare Two Different "NMB + Reversal" Strategies in Adult Obese Patients Undergoing Laparoscopic Abdominal Surgery

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02410590
• Other study ID #: 8616-104
• Secondary ID: 2013-004423-36
• Status: Withdrawn
• Phase: Phase 4
• First received: April 2, 2015
• Last updated: July 10, 2015
• Start date: July 2015
• Est. completion date: October 2016

Study information

• Verified date: July 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Italian Health Authority
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Neuromuscular Blockade

Intervention

Drug:
• Rocuronium

• Sugammadex

• Cisatracurium

• Neostigmine/Atropine

• Succinylcholine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Surgeons who prefer Rocuronium + Sugammadex vs. Succinylcholine + Cisatracurium + Neostigmine/Atropine for neuromuscular blocking/reversal in obese participants undergoing laparoscopic abdominal surgery		Up to 1 hour after end of surgery	No
Secondary	Time elapsed from end of surgery to extubation		Up to 1 hour after end of surgery	No
Secondary	Time elapsed from start of reversal drug administration to train-of-four (TOF) ratio =0.9		Up to 1 hour after start of reversal drug treatment	No