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Completed

NCT Number: NCT02762890

Comparison of Deep Neuromuscular Block and Moderate Neuromuscular Block on Quality of Recovery in Patients Undergoing Robotic Gastrectomy

The purpose of this study is to investigate and compare the postoperative quality of recovery between the deep neuromuscular blockade and moderate neuromuscular blockade during robotic gastrectomy.

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Key information

Conditions

General Anesthesia

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology and Pain Medicine Anesthesia and Pain Research Institute Yonsei University

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • adult patients aged 19-80 years who are scheduled for robotic gastrectomy

Exclusion criteria

  • Neuromuscular disease
  • History of malignant hyperthermia
  • Significant renal or hepatic dysfunction
  • Allergy to sugammadex or rocuronium

Treatment and study plan

Deep neuromuscular blockade

Drug

neuromuscular blockade will be performed using a continuous infusion of rocuronium. Post-tetanic count 1-2 will be maintained during surgery. After the end of surgery, sugammadex of 4 mg/kg will be administered to reverse neuromuscular blockade.

Moderate Neuromuscular Blockade

Drug

neuromuscular blockade will be performed using a continuous infusion of rocuronium. Train-of-four 1-2 will be maintained during surgery. After the end of surgery, sugammadex of 2 mg/kg will be administered to reverse neuromuscular blockade.

Primary outcomes

  1. Postoperative quality of recovery

    Time frame: within 48 hours after the end of surgery.

    The postoperative quality of recovery will be evaluated at 24 and 48 hours after the end of surgery by the investigator who are blinded to the group assignments.

Secondary outcomes

  1. Surgical condition

    Time frame: within 48 hours after the end of surgery

    Surgical condition will be evaluated after the end of surgery by the investigator who are blinded to the group assignments.

  2. shoulder pain

    Time frame: within 48 hours after the end of surgery

    shoulder pain will be evaluated after the end of surgery by the investigator who are blinded to the group assignments.

  3. abdominal pain

    Time frame: within 48 hours after the end of surgery

    abdominal pain will be evaluated after the end of surgery by the investigator who are blinded to the group assignments.

  4. nausea and vomiting

    Time frame: within 48 hours after the end of surgery

    nausea and vomiting will be evaluated after the end of surgery by the investigator who are blinded to the group assignments.

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 5, 2016
Registry last updated
Dec 18, 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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