Deep vs Moderate Neuromuscular Blockade in Day Case Laparoscopic Cholecystectomy.

Muscle Relaxation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03881423
• Other study ID #: wbakhet
• Status: Completed
• Phase: Phase 4
• Start date: April 1, 2017
• Est. completion date: July 1, 2019

Study information

• Verified date: October 2019
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 1, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

Inclusion Criteria:

• ASA I and II

Exclusion Criteria:

• Neuromuscular disorders

Related Conditions & MeSH terms

• Muscle Relaxation

Intervention

Drug:
• Rocuronium Bromide
DEEP block to PTC 1-3

Locations

Country	Name	City	State
Egypt	Ainshams University Hospitals	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Wahba bakhet	Elite medical center

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical conditions	The surgeon assessed surgical condition every 10 minutes	Intraoperative
Primary	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	Postoperative pain	Visual analogue scale with its 0 to 10 score range: (0 (no pain) to 10 ( Severe pain)	During the length of hospital stay post surgery (on average 24 hours)