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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02469831
Other study ID # low pressure lap chole.
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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