Study Stopped
financial protocol
the Effect of Dexmedetomidine and Licodaine on Acute Postoperative Pain in Gynecological Laparoscopy
The Effect of Opioid-free Anesthesia Using Dexmedetomidine-lidocaine on Acute Postoperative Pain in Gynecological Laparoscopy
1 other identifier
interventional
N/A
1 country
2
Brief Summary
The aim of this study is to investigate the effect of opioid-free anesthesia using dexmedetomidine and lidocaine instead of remifentanil infusion, on the acute postoperative pain after the gynecological laparoscopy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2021
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 25, 2021
CompletedFirst Posted
Study publicly available on registry
May 28, 2021
CompletedStudy Start
First participant enrolled
June 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2022
CompletedJanuary 12, 2023
January 1, 2023
12 months
May 25, 2021
January 10, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
postoperative pain in recovery room
The pain level is assessed by using NRS (numeric rating scale; 0=no pain , 10=the worst pain)
30 minuetes after the completion of surgery
Secondary Outcomes (2)
shivering in recovery room
30 minuetes after the completion of surgery
postoperative nausea and vomiting (PONV)
30 minutes after the completion of surgery
Study Arms (2)
dexmedetomidine-lidocaine
EXPERIMENTALThe study group receives the dexmedetomidine and lidocaine infusion with general anesthesia for gynecological laparoscopy.
remifentanil
ACTIVE COMPARATORThe control group receives the remifentanil infusion with general anesthesia for gynecological laparoscopy
Interventions
dexmedetomidine iv bolus for 10 minutes followed by the infusion of 0.1-1 ug/kg/h during general anesthesia
remifentanil iv infusion of 0.5-5 ng/ml (effect site concentration using TCI) during general anesthesia
lidocaine iv bolus followed by the infusion of 1.5mg/kg/h during general anesthesia
Eligibility Criteria
You may qualify if:
- patients scheduled for elective gynecological laparoscopy
You may not qualify if:
- emergent surgery
- cancer surgery
- chronic pain requiring pain killers
- psychiatric disease
- preoperative bradycardia (HR \< 50 bpm)
- allergies
- pregnancy or breast feeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Seoul St.Mary's Hospital
Seoul, Seocho-gu, 06591, South Korea
Seoul St.Mary's Hospital
Seocho, 06591, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Young Eun Moon, MD, PhD
Associate professor, Department of Anesthesiology and Pain Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
May 25, 2021
First Posted
May 28, 2021
Study Start
June 1, 2021
Primary Completion
May 30, 2022
Study Completion
June 1, 2022
Last Updated
January 12, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share