Respiratory Mechanics and Metabolic Changes During Low Pressure Laparoscopic Cholecystectomy

NCT ID: NCT02469831

Last Updated: 2017-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Laparoscopic Cholecystectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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group D

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

Group Type ACTIVE_COMPARATOR

Rocuronium

Intervention Type DRUG

group I

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

Group Type ACTIVE_COMPARATOR

Rocuronium

Intervention Type DRUG

Interventions

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Rocuronium

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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khaled salah mohamed

lecturer of anaesthesia and ICU

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Osama ibraheim, MD

Role: STUDY_CHAIR

Assiut University

MOSTAFA ABBAS, MD

Role: STUDY_CHAIR

Assiut University

AHMED TAHA, MD

Role: STUDY_CHAIR

Assiut University

Locations

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Al Rajhy liver hospital

Asyut, Asyut Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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low pressure lap chole.

Identifier Type: -

Identifier Source: org_study_id

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