Randomized, parallel group, controlled trial to compare two different NMB + reversal” strategies in adult obese patients underwent laparoscopic abdominal surgery (Phase 4; Protocol No. MK-8616-104-00)

Phase 1

Active, not recruiting

• Conditions: Obese adults to be subjected to abdominal laparoscopic surgery; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2013-004423-36-IT
• Lead Sponsor: MSD Italia s.r.l.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-18
• Last Update Posted: 12 March 2018

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 178

Inclusion Criteria

The patient should be obese, defined as Body Mass Index =30.0
? The patient should be scheduled for elective laparoscopic abdominal surgery with general anesthesia
? The patient should be classified as ASA Class 1, 2, or 3
? The patient should be able to understand the questionnaires in order to give reliable answers
? The patient must have an arm accessible during surgery for the monitoring of the block with the TOF Watch SX® that will be used for the purpose of monitoring neuro-muscular transmission
? The patient should have the results of laboratory tests (CBC, biochemistry) within normal limits or clinically acceptable to the investigator / sponsor
? The patient must have the results of the physical examination, including blood pressure within normal limits or clinically acceptable to the investigator / sponsor
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 178
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

? The patient malformations that could embarrass the intubation
? The patient has neuromuscular disorders that can affect the neuro-muscular blocking and / or assessments of the study
? The patient has already made other abdominal laparoscopic procedures
? The patient has no history of chronic pain, defined as opioids or NSAIDs within 7 days before surgery
? Female patients of childbearing age who have given birth in the previous 12 months or are pregnant or plan to become pregnant between randomization and the contact of Day 30 pregnancy follow-up
? The patient has evidence of acute cholecystitis
? The patient dialysis-dependent renal failure or has suspected severe renal impairment (defined as estimated creatinine clearance <30 mL / min).
? significant hepatic dysfunction, which may prevent the patient to participate in the study by the investigator based on the RCP of the study drugs
? The patient has a history or family history of malignant hypothermia
? The patient has a known allergy to the study treatments or their ingredients, opioids / opiates, or other medicines used during general anesthesia
? Transfer UCI after surgery
? The patient received one of the treatments in Table 1, more recently, by the period of wash-out
? The patient should continue taking during the study one of the treatments listed in Table 1

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified