Deep NMB in Ambulatory Gynecological Laparoscopy

NCT04105764 | Completed Phase 4 DMC

• 1 other identifier: elite NMB
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Gynecological laparoscopic surgery is commonly performed as an ambulatory basis for the aim of rapid discharge, reduce hospital stay with reduced costs and to improve postoperative QOR \[1,2\]. However, the creation of pneumoperitoneum during laparoscopy may cause postoperative pain and other physiological changes \[3\], which could influence the postoperative QOR negatively \[4\]. Poor postoperative QOR leads to prolonged hospital stay \[5\].

Conditions

Muscle Relaxation

Outcome Measures

Primary Outcomes (1)

• Quality of recovery

  Quality of recovery-40 (QoR-40) questionnaire, which includes five general quality of life dimensions: physical independence (5 items), pain (7 items), .emotional state (9 items), psychological support (7 items), and physical independence (5 items). Each item was graded with a 5-point score: none of the time, some of the time,usually, most of the time and all of the time. The total score on the QoR- 40 questionnaire ranges from 40 to 200 representing, respectively, extremely poor to excellent

  24 hours postoperative

Secondary Outcomes (1)

• Postoperative pain

  During the length of hospital stay post surgery (on average 24 hours)

Study Arms (2)

DEEP BLOCK

ACTIVE COMPARATOR

In the deep NMB-group, a PTC of 1 to 2 twitches was maintained, and NMB was reversed with sugammadex at the end of surgery.

Drug: Rocuronium

Moderate block

ACTIVE COMPARATOR

In the moderate NMB group, a TOF count of 1 to 2 was maintained and NMB was reversed with a combination of neostigmine and glycopyrolate at the end of surgery.

Drug: Rocuronium bromide

Interventions

Rocuronium DRUG

DEEP block to PTC 1-3

Also known as: Neuromuscular blocker

DEEP BLOCK

Rocuronium bromide DRUG

MODERATE block to TOF1-2

Also known as: Neuromuscular blocker

Moderate block

Eligibility Criteria

• Age: 21 Years - 60 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ASA I and II

You may not qualify if:

• Neuromuscular disorders

Sponsors & Collaborators

• Wahba bakhet: lead
• Elite medical center: collaborator

Study Sites (1)

Elite Medical Center

Kuwait City, 002, Kuwait

Location

MeSH Terms

Interventions

Rocuronium; Neuromuscular Blocking Agents

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Neuromuscular Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: LECTRURE

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: September 26, 2019
• Study Start: December 1, 2016
• Primary Completion: November 1, 2018
• Study Completion: June 15, 2019
• Last Updated: December 10, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 1 YEAR
• Access Criteria: Web

Locations

KU (1)