Deep vs Moderate Neuromuscular Blockade in Day Case Laparoscopic Cholecystectomy.

NCT ID: NCT03881423

Last Updated: 2019-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-01

Study Completion Date

2019-07-01

Brief Summary

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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

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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 .

Conditions

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Muscle Relaxation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
Double blinded

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Rocuronium Bromide

Intervention Type DRUG

DEEP block to PTC 1-3

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.

Group Type ACTIVE_COMPARATOR

Rocuronium Bromide

Intervention Type DRUG

DEEP block to PTC 1-3

Interventions

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Rocuronium Bromide

DEEP block to PTC 1-3

Intervention Type DRUG

Other Intervention Names

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Neuromuscular blocker

Eligibility Criteria

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Inclusion Criteria

* ASA I and II

Exclusion Criteria

* Neuromuscular disorders
Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Elite medical center

UNKNOWN

Sponsor Role collaborator

Wahba bakhet

OTHER

Sponsor Role lead

Responsible Party

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Wahba bakhet

Lecturer

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Ainshams University Hospitals

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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wbakhet

Identifier Type: -

Identifier Source: org_study_id

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