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Completed

NCT Number: NCT02469831

Respiratory Mechanics and Metabolic Changes During Low Pressure Laparoscopic Cholecystectomy

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.

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Key information

Conditions

Laparoscopic Cholecystectomy

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Al Rajhy liver hospital

Asyut, Asyut Governorate, 71515, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rocuronium

Drug

Primary outcomes

  1. respiratory mechanics (Dynamic compliance)

    Time frame: intraoperative

    Dynamic compliance

Secondary outcomes

  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

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study 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.

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Jun 12, 2015
Registry last updated
Mar 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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