Back to resultsthe Effect of Dexmedetomidine and Licodaine on Acute Postoperative Pain in Gynecological Laparoscopy
Primary Purpose
Gynecologic Disease
Status
Withdrawn
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Dexmedetomidine Hydrochloride
Remifentanil Hydrochloride
Lidocaine Hydrochloride
Sponsored by
About this trial
This is an interventional supportive care trial for Gynecologic Disease
Eligibility Criteria
Inclusion Criteria:
- patients scheduled for elective gynecological laparoscopy
Exclusion Criteria:
- emergent surgery
- cancer surgery
- chronic pain requiring pain killers
- psychiatric disease
- preoperative bradycardia (HR < 50 bpm)
- allergies
- pregnancy or breast feeding
Sites / Locations
- Seoul St.Mary's Hospital
- Seoul St.Mary's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
dexmedetomidine-lidocaine
remifentanil
Arm Description
The study group receives the dexmedetomidine and lidocaine infusion with general anesthesia for gynecological laparoscopy.
The control group receives the remifentanil infusion with general anesthesia for gynecological laparoscopy
Outcomes
Primary Outcome Measures
postoperative pain in recovery room
The pain level is assessed by using NRS (numeric rating scale; 0=no pain , 10=the worst pain)
Secondary Outcome Measures
shivering in recovery room
The incidence of shivering is assessed by questioning Yes or No.
postoperative nausea and vomiting (PONV)
The incidence of PONV is assessed by questioning Yes or No
Full Information
NCT ID
NCT04906889
First Posted
May 25, 2021
Last Updated
January 10, 2023
Sponsor
The Catholic University of Korea
1. Study Identification
Unique Protocol Identification Number
NCT04906889
Brief Title
the Effect of Dexmedetomidine and Licodaine on Acute Postoperative Pain in Gynecological Laparoscopy
Official Title
The Effect of Opioid-free Anesthesia Using Dexmedetomidine-lidocaine on Acute Postoperative Pain in Gynecological Laparoscopy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Withdrawn
Why Stopped
financial protocol
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
May 30, 2022 (Anticipated)
Study Completion Date
June 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Catholic University of Korea
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
Detailed Description
This study is performed to investigate the effect of dexmedetomidine and lidocaine the postopeative pain, shivering, nausea and vomiting after the gynecological laparoscopy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gynecologic Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
dexmedetomidine-lidocaine
Arm Type
Experimental
Arm Description
The study group receives the dexmedetomidine and lidocaine infusion with general anesthesia for gynecological laparoscopy.
Arm Title
remifentanil
Arm Type
Active Comparator
Arm Description
The control group receives the remifentanil infusion with general anesthesia for gynecological laparoscopy
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine Hydrochloride
Other Intervention Name(s)
precedex
Intervention Description
dexmedetomidine iv bolus for 10 minutes followed by the infusion of 0.1-1 ug/kg/h during general anesthesia
Intervention Type
Drug
Intervention Name(s)
Remifentanil Hydrochloride
Other Intervention Name(s)
remifentanil
Intervention Description
remifentanil iv infusion of 0.5-5 ng/ml (effect site concentration using TCI) during general anesthesia
Intervention Type
Drug
Intervention Name(s)
Lidocaine Hydrochloride
Other Intervention Name(s)
lidocaine
Intervention Description
lidocaine iv bolus followed by the infusion of 1.5mg/kg/h during general anesthesia
Primary Outcome Measure Information:
Title
postoperative pain in recovery room
Description
The pain level is assessed by using NRS (numeric rating scale; 0=no pain , 10=the worst pain)
Time Frame
30 minuetes after the completion of surgery
Secondary Outcome Measure Information:
Title
shivering in recovery room
Description
The incidence of shivering is assessed by questioning Yes or No.
Time Frame
30 minuetes after the completion of surgery
Title
postoperative nausea and vomiting (PONV)
Description
The incidence of PONV is assessed by questioning Yes or No
Time Frame
30 minutes after the completion of surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients scheduled for elective gynecological laparoscopy
Exclusion Criteria:
emergent surgery
cancer surgery
chronic pain requiring pain killers
psychiatric disease
preoperative bradycardia (HR < 50 bpm)
allergies
pregnancy or breast feeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young Eun Moon, MD, PhD
Organizational Affiliation
Associate professor, Department of Anesthesiology and Pain Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul St.Mary's Hospital
City
Seoul
State/Province
Seocho-gu
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Seoul St.Mary's Hospital
City
Seocho
ZIP/Postal Code
06591
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
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the Effect of Dexmedetomidine and Licodaine on Acute Postoperative Pain in Gynecological Laparoscopy
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