the Effect of Opioid-free General Anesthesia

Gynecologic Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04409964
• Other study ID #: OFGA
• Status: Completed
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: September 20, 2021

Study information

• Verified date: February 2022
• Source: The Catholic University of Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: September 20, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• patient scheduled for gynecological laparoscopic surgery

Exclusion Criteria:

1. refusal to participate in this study

2. emergent surgery

3. chronic pain requiring for pain killer

4. psychiatric disease

5. preoperative bradycardia or hypotension

6. allergy or history of the adverse effect to study drug

7. pregnancy or lactation

Related Conditions & MeSH terms

• Gynecologic Disease

Intervention

Drug:
• Dexmedetomidine Hydrochloride
dexmedetomidine iv bolus followed by the infusion of 0.1-1 ug/kg/hr during general anesthesia
• Lidocaine Hydrochloride
lidocaine iv bolus followed by the infusion of 1.5 mg/kg/hr during general anesthesia
• Remifentanil Hydrochloride
remifentanil iv infusion of 0.5-5 ng/ml (effect site concentration using TCI) during general anesthesia

Locations

Country	Name	City	State
Korea, Republic of	Seoul St.Mary's Hospital	Seoul	Seocho-gu
Korea, Republic of	Seoul St.Mary's Hospital	Seoul	Seocho-gu

Sponsors (1)

Lead Sponsor	Collaborator
The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the quality of recovery	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.	at 24 hour after the completion of surgery
Secondary	cytokine	as ancillary study, to assess the various kinds of cytokines such as epinephrine, norepinephrine, interleukin-10, tumor necrosis factor-alpha.	during surgery