Deep vs Moderate Neuromuscular Blockade in Day Case Laparoscopic Cholecystectomy.

Phase 4

Completed

• Conditions: Muscle Relaxation
• Interventions: Drug: Rocuronium Bromide

• Registration Number: NCT03881423
• Lead Sponsor: Wahba bakhet

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 .

Detailed Description

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.

The surgeon requires a good surgical conditions to perform the operation, whereas the anesthesiologist is concerned with postoperative QOR. Pneumoperitoneium -associated expansion of the abdominal cavity during LC is related to postoperative pain.

and other physiological changes, affecting the postoperative QOR negatively . Poor postoperative QOR leads to prolonged hospital stay .

Study Timeline

• Study Start: 2017-04-01
• Study First Submitted: 2019-03-16
• Study First Submitted QC: 2019-03-18
• Study First Posted: 2019-03-19
• Primary Completion: 2019-04-01
• Study Completion: 2019-07-01
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-25
• Last Update Posted: 2019-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• ASA I and II

Exclusion Criteria

• Neuromuscular disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Deep block	Rocuronium Bromide	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.
Moderate block	Rocuronium Bromide	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.

Primary Outcome Measures

Name	Time	Method
Quality of recovery	24 hours postoperative	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
Surgical conditions	Intraoperative	The surgeon assessed surgical condition every 10 minutes

Secondary Outcome Measures

Name	Time	Method
Postoperative pain	During the length of hospital stay post surgery (on average 24 hours)	Visual analogue scale with its 0 to 10 score range: (0 (no pain) to 10 ( Severe pain)

Trial Locations

Locations (1)

Ainshams University Hospitals; 🇪🇬 Cairo, Egypt