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Respiratory Mechanics and Metabolic Changes During Low Pressure Laparoscopic Cholecystectomy

The Impact of Deep Versus Moderate Neuromuscular Block on Respiratory System Mechanics and Metabolic Changes During Laparoscopic Cholecystectomy a Double-Blind Randomized Clinical Trial.

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02469831
Enrollment
40
Registered
2015-06-12
Start date
2014-10-31
Completion date
2016-01-31
Last updated
2017-03-28

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

Conditions

Laparoscopic Cholecystectomy

Brief summary

The investigators aim to investigate the differences between deep continuous muscle relaxation and moderate blockade during low-pressure (8 mmHg) laparoscopic cholecystectomy in respect to metabolic changes and respiratory mechanics.

Interventions

DRUGRocuronium

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* more than 18 years * undergoing elective laparoscopic cholecystectomy

Exclusion criteria

* previous surgeries, * a history of venous or arterial diseases, * BMI (≥30 kg/m2), * Allergy to rocuronium. * Significant liver dysfunction. * Significant renal dysfunction (S-creatinine \> 200 umol/l). * Neuromuscular disease that might impair neuromuscular blockade * Pregnant or breastfeeding. * Indication for rapid sequence induction. * Inability to informed consent

Design outcomes

Primary

MeasureTime frameDescription
respiratory mechanics (Dynamic compliance)intraoperativeDynamic compliance

Secondary

MeasureTime frameDescription
surgeon satisfaction (scale from 1 to 5)intraoperativescale from 1 to 5
postoperative pain (VAS score)postoperative for 6 hoursVAS score
postoperative nausea and vomitingpostoperative for 6 hours
completion of surgical procedureintraoperativeyes or no
metabolic changes (blood lactate)intraoperativeblood lactate

Countries

Egypt

Outcome results

None listed

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