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Respiratory Mechanics and Metabolic Changes During Low Pressure Laparoscopic Cholecystectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02469831
Recruitment Status : Completed
First Posted : June 12, 2015
Last Update Posted : March 28, 2017
Sponsor:
Information provided by (Responsible Party):
khaled salah mohamed, Assiut University

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.

Condition or disease Intervention/treatment Phase
Laparoscopic Cholecystectomy Drug: Rocuronium Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
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.
Study Start Date : October 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: group D
deep neuromuscular block by rocuronium defined :post tetanic (PTC) >1 but no response to a train of four (TOF) stimulation.
Drug: Rocuronium
Active Comparator: group I
intermediate neuromuscular block by rocuronium defined as TOF count of 1-3.
Drug: Rocuronium



Primary Outcome Measures :
  1. respiratory mechanics (Dynamic compliance) [ Time Frame: intraoperative ]
    Dynamic compliance


Secondary Outcome Measures :
  1. surgeon satisfaction (scale from 1 to 5) [ Time Frame: intraoperative ]
    scale from 1 to 5

  2. postoperative pain (VAS score) [ Time Frame: postoperative for 6 hours ]
    VAS score

  3. postoperative nausea and vomiting [ Time Frame: postoperative for 6 hours ]
  4. completion of surgical procedure [ Time Frame: intraoperative ]
    yes or no

  5. metabolic changes (blood lactate) [ Time Frame: intraoperative ]
    blood lactate



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02469831


Locations
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Egypt
Al Rajhy liver hospital
Assuit, اسيوط, Egypt, 71515
Sponsors and Collaborators
Assiut University
Investigators
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Study Chair: Osama ibraheim, MD Assiut University
Study Chair: MOSTAFA ABBAS, MD Assiut University
Study Chair: AHMED TAHA, MD Assiut University
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Responsible Party: khaled salah mohamed, lecturer of anaesthesia and ICU, Assiut University
ClinicalTrials.gov Identifier: NCT02469831    
Other Study ID Numbers: low pressure lap chole.
First Posted: June 12, 2015    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Rocuronium
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs