Skip to content

Deep vs Moderate Neuromuscular Blockade in Day Case Laparoscopic Cholecystectomy.

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03881423
Enrollment
80
Registered
2019-03-19
Start date
2017-04-01
Completion date
2019-07-01
Last updated
2019-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscle Relaxation

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 .

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 .

Interventions

DRUGRocuronium Bromide

DEEP block to PTC 1-3

Sponsors

Elite medical center
CollaboratorUNKNOWN
Wahba bakhet
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)

Masking description

Double blinded

Eligibility

Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* ASA I and II

Exclusion criteria

* Neuromuscular disorders

Design outcomes

Primary

MeasureTime frameDescription
Surgical conditionsIntraoperativeThe surgeon assessed surgical condition every 10 minutes
Quality of recovery24 hours postoperativeQuality 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

MeasureTime frameDescription
Postoperative painDuring 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)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026