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CompletedNCT03881423Updated Oct 29, 2019

Deep vs Moderate Neuromuscular Blockade in Day Case Laparoscopic Cholecystectomy.

A Phase 4 interventional study of Rocuronium Bromide in Muscle Relaxation, sponsored by Wahba bakhet. Completed at 1 site in Egypt. Open to participants aged 21 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-29.

Sponsored by Wahba bakhet · Phase 4, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year 11 months after the study started (first participant enrolled Apr 2017, registered Mar 2019).
Phase
Phase 4
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
21 Years to 60 Years
Sex
All
01

Study 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 .

Read the 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 .

02

Conditions studied

  • Muscle Relaxation
03

In context

Lead sponsor

Wahba bakhet is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • ASA I and II

Exclusion criteria

Exclusion Criteria:

  • Neuromuscular disorders
05

Study design

Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
80 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • DrugRocuronium Bromide

    DEEP block to PTC 1-3

    Also known as: Neuromuscular blocker

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What researchers measure

Primary outcomes

  1. Surgical conditions

    The surgeon assessed surgical condition every 10 minutes

    Time frame: Intraoperative

  2. 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

    Time frame: 24 hours postoperative

Secondary outcomes

  1. Postoperative pain

    Visual analogue scale with its 0 to 10 score range: (0 (no pain) to 10 ( Severe pain)

    Time frame: During the length of hospital stay post surgery (on average 24 hours)

07

Study locations

1 site
  • Ainshams University Hospitals
    Cairo, 11311, Egypt
08

References and documents

Individual participant data

Plan to share: Yes — Sharing

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 29, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03881423
Lead sponsor
Wahba bakhet
Collaborators
Elite medical center
Responsible party
Wahba bakhet (Lecturer, Ain Shams University) — Sponsor-investigator
First posted
Mar 19, 2019
Start date
Apr 1, 2017
Primary completion
Apr 1, 2019
Completion
Jul 1, 2019
Last update
Oct 29, 2019

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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