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Clinical Trials/NCT03881423
NCT03881423
Completed
Phase 4

Deep vs Moderate Neuromuscular Blockade on Surgical Conditions and Quality of Recovery in Day Case Laparoscopic Cholecystectomy

Wahba bakhet1 site in 1 country80 target enrollmentApril 1, 2017

Overview

Phase
Phase 4
Intervention
Rocuronium Bromide
Conditions
Muscle Relaxation
Sponsor
Wahba bakhet
Enrollment
80
Locations
1
Primary Endpoint
Quality of recovery
Status
Completed
Last Updated
6 years ago

Overview

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 .

Registry
clinicaltrials.gov
Start Date
April 1, 2017
End Date
July 1, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Wahba bakhet
Responsible Party
Sponsor Investigator
Principal Investigator

Wahba bakhet

Lecturer

Ain Shams University

Eligibility Criteria

Inclusion Criteria

  • ASA I and II

Exclusion Criteria

  • Neuromuscular disorders

Arms & Interventions

Deep block

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.

Intervention: Rocuronium Bromide

Moderate block

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.

Intervention: Rocuronium Bromide

Outcomes

Primary Outcomes

Quality of recovery

Time Frame: 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

Time Frame: Intraoperative

The surgeon assessed surgical condition every 10 minutes

Secondary Outcomes

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

Study Sites (1)

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