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Completed

NCT Number: NCT04409964

the Effect of Opioid-free General Anesthesia

This study is performed to investigate the effect of opioid-free general anesthesia on the recovery quality after gynecological laparoscopy.

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Key information

Conditions

Gynecologic Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

20 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Seoul St.Mary's Hospital, Seoul, Seocho-gu, South Korea

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About this study

The quality of recovery after the surgery is assessed using the QoR 40. In addition, the various kinds of cytokine are assessed for the ancillary study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patient scheduled for gynecological laparoscopic surgery

Exclusion criteria

  • refusal to participate in this study
  • emergent surgery
  • chronic pain requiring for pain killer
  • psychiatric disease
  • preoperative bradycardia or hypotension
  • allergy or history of the adverse effect to study drug
  • pregnancy or lactation

Treatment and study plan

Dexmedetomidine Hydrochloride

Drug

dexmedetomidine iv bolus followed by the infusion of 0.1-1 ug/kg/hr during general anesthesia

Other names: precedex

Lidocaine Hydrochloride

Drug

lidocaine iv bolus followed by the infusion of 1.5 mg/kg/hr during general anesthesia

Other names: lidocaine

Remifentanil Hydrochloride

Drug

remifentanil iv infusion of 0.5-5 ng/ml (effect site concentration using TCI) during general anesthesia

Other names: remifentanil

Primary outcomes

  1. the quality of recovery

    Time frame: at 24 hour after the completion of surgery

    The quality of recovery is assessed using questionnaire. This questionnaire includes 40 items. The score range is from 40 to 200. The higher score means the better quality of recovery after surgery.

Secondary outcomes

  1. cytokine

    Time frame: during surgery

    as ancillary study, to assess the various kinds of cytokines such as epinephrine, norepinephrine, interleukin-10, tumor necrosis factor-alpha.

Sponsors and collaborators

Lead sponsor

The Catholic University of Korea

Other

Registry information

Official study title

the Effect of Opioid-free General Anesthesia on the Recovery Quality After Gynecological Laparoscopy

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 1, 2020
Registry last updated
Feb 22, 2022

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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