Respiratory Mechanics and Metabolic Changes During Low Pressure Laparoscopic Cholecystectomy

Assiut University

Status and phase: Completed; Phase 2

Conditions: Laparoscopic Cholecystectomy

Treatments: Drug: Rocuronium

Study type: Interventional

Funder types: Other

Identifiers

NCT02469831

low pressure lap chole.

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

group D

Active Comparator group

Description:

deep neuromuscular block by rocuronium defined :post tetanic (PTC) \>1 but no response to a train of four (TOF) stimulation.

Treatment:

Drug: Rocuronium

group I

Active Comparator group

Description:

intermediate neuromuscular block by rocuronium defined as TOF count of 1-3.

Treatment:

Drug: Rocuronium