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Deep vs Moderate Neuromuscular Blockade in Ambulatory Laparoscopic Cholecystectomy.

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ClinicalTrials.gov Identifier: NCT03881423
Recruitment Status : Not yet recruiting
First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Wahba bakhet, Ain Shams University

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 .

Condition or disease Intervention/treatment Phase
Muscle Relaxation Drug: Rocuronium Bromide Early Phase 1

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 .


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: Deep vs Moderate Neuromuscular Blockade on Surgical Conditions and Quality of Recovery in Ambulatory Laparoscopic Cholecystectomy
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Drug: Rocuronium Bromide
DEEP block to PTC 1-3
Other Name: Neuromuscular blocker

Active Comparator: 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.
Drug: Rocuronium Bromide
DEEP block to PTC 1-3
Other Name: Neuromuscular blocker




Primary Outcome Measures :
  1. Surgical conditions [ Time Frame: Intraoperative ]
    The surgeon assessed surgical condition every 10 minutes

  2. 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


Secondary Outcome Measures :
  1. Postoperative pain [ Time Frame: 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)



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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ASA I and II

Exclusion Criteria:

  • Neuromuscular disorders

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Responsible Party: Wahba bakhet, Lecturer, Ain Shams University
ClinicalTrials.gov Identifier: NCT03881423     History of Changes
Other Study ID Numbers: AinShamsU-wbakhet
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Sharing
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: 1 year
Access Criteria: Web

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Rocuronium
Neuromuscular Blocking Agents
Bromides
Neuromuscular Nondepolarizing Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants