Respiratory Mechanics and Metabolic Changes During Low Pressure Laparoscopic Cholecystectomy

Laparoscopic Cholecystectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02469831
• Other study ID #: low pressure lap chole.
• Status: Completed
• Phase: Phase 2
• First received: May 24, 2015
• Last updated: March 25, 2017
• Start date: October 2014
• Est. completion date: January 2016

Study information

• Verified date: March 2017
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Laparoscopic Cholecystectomy

Intervention

Drug:
• Rocuronium

Locations

Country	Name	City	State
Egypt	Al Rajhy liver hospital	Assuit	?????

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	respiratory mechanics (Dynamic compliance)	Dynamic compliance	intraoperative
Secondary	surgeon satisfaction (scale from 1 to 5)	scale from 1 to 5	intraoperative
Secondary	postoperative pain (VAS score)	VAS score	postoperative for 6 hours
Secondary	postoperative nausea and vomiting		postoperative for 6 hours
Secondary	completion of surgical procedure	yes or no	intraoperative
Secondary	metabolic changes (blood lactate)	blood lactate	intraoperative