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the Effect of Opioid-free General Anesthesia

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04409964
Enrollment
78
Registered
2020-06-01
Start date
2020-06-01
Completion date
2021-09-20
Last updated
2022-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gynecologic Disease

Brief summary

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

Detailed 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.

Interventions

DRUGDexmedetomidine Hydrochloride

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

DRUGLidocaine Hydrochloride

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

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

Sponsors

The Catholic University of Korea
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
the quality of recoveryat 24 hour after the completion of surgeryThe 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

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026