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OpenTrials
Completed

NCT Number: NCT03881423

Deep vs Moderate Neuromuscular Blockade in Day Case Laparoscopic Cholecystectomy.

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 .

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Key information

Conditions

Muscle Relaxation

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ainshams University Hospitals

Cairo, 11311, Egypt

About this study

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 .

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA I and II

Exclusion criteria

  • Neuromuscular disorders

Treatment and study plan

Rocuronium bromide

Drug

DEEP block to PTC 1-3

Other names: Neuromuscular blocker

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Wahba bakhet

Other

Collaborators

  • Elite medical center

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 19, 2019
Registry last updated
Oct 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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