Deep vs Moderate Neuromuscular Blockade in Day Case Laparoscopic Cholecystectomy.

NCT03881423 | Completed Phase 4 DMC

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

Brief Summary

Laparoscopic cholecystectomy (LC) is commonly performed on ambulatory basis as a result of its ability to improve postoperative quality of recovery (QOR) and significantly reduce hospital stay .

Conditions

Muscle Relaxation

Outcome Measures

Primary Outcomes (2)

• Surgical conditions

  The surgeon assessed surgical condition every 10 minutes

  Intraoperative

• 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 Bromide

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 Bromide DRUG

DEEP block to PTC 1-3

Also known as: Neuromuscular blocker

Deep block; Moderate block

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• 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)

Ainshams University Hospitals

Cairo, 11311, Egypt

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, INVESTIGATOR
• Masking Details: Double blinded
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: March 16, 2019
• First Posted: March 19, 2019
• Study Start: April 1, 2017
• Primary Completion: April 1, 2019
• Study Completion: July 1, 2019
• Last Updated: October 29, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 1 year
• Access Criteria: Web

Locations

EG (1)