Gynecologic DiseaseNCT04906889
the Effect of Dexmedetomidine and Licodaine on Acute Postoperative Pain in Gynecological Laparoscopy
A study testing Dexmedetomidine Hydrochloride, Remifentanil Hydrochloride and Lidocaine Hydrochloride in people with Gynecologic Disease, run by The Catholic University of Korea at 2 sites in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Gynecologic Disease
- What is being tested?
- Dexmedetomidine Hydrochloride, Remifentanil Hydrochloride and Lidocaine Hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 1 Jun 2021to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients scheduled for elective gynecological laparoscopy
Who cannot join
- emergent surgery
- cancer surgery
- chronic pain requiring pain killers
- psychiatric disease
- preoperative bradycardia (HR < 50 bpm)
- allergies
- pregnancy or breast feeding
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Seoul St.Mary's Hospital
Seocho, 06591
Seoul St.Mary's Hospital
Seoul, Seocho-gu, 06591
About this study
Official title: The Effect of Opioid-free Anesthesia Using Dexmedetomidine-lidocaine on Acute Postoperative Pain in Gynecological Laparoscopy
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
Read the 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.
- Conditions
- Gynecologic Disease
- Being tested
- Dexmedetomidine Hydrochloride, Remifentanil Hydrochloride, Lidocaine Hydrochloride
- Medical subject headings
- Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine HydrochlorideDrug
Also called precedex
dexmedetomidine iv bolus for 10 minutes followed by the infusion of 0.1-1 ug/kg/h during general anesthesia
Remifentanil HydrochlorideDrug
Also called remifentanil
remifentanil iv infusion of 0.5-5 ng/ml (effect site concentration using TCI) during general anesthesia
Lidocaine HydrochlorideDrug
Also called lidocaine
lidocaine iv bolus followed by the infusion of 1.5mg/kg/h during general anesthesia
| Study group | Role | What they receive |
|---|---|---|
| dexmedetomidine-lidocaine | Experimental | The study group receives the dexmedetomidine and lidocaine infusion with general anesthesia for gynecological laparoscopy. Receives: Drug: Dexmedetomidine Hydrochloride; Drug: Lidocaine Hydrochloride |
| remifentanil | Active comparator | The control group receives the remifentanil infusion with general anesthesia for gynecological laparoscopy Receives: Drug: Remifentanil Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain in recovery room
The pain level is assessed by using NRS (numeric rating scale; 0=no pain , 10=the worst pain)
Measured: 30 minuetes after the completion of surgery
Secondary outcomes (2)
shivering in recovery room
The incidence of shivering is assessed by questioning Yes or No.
Measured: 30 minuetes after the completion of surgery
postoperative nausea and vomiting (PONV)
The incidence of PONV is assessed by questioning Yes or No
Measured: 30 minutes after the completion of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start1 Jun 2021
- Primary completion30 May 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Why it stopped: financial protocol
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Eun Moon, The Catholic University of Korea
- Investigators
- Young Eun Moon, MD, PhD, Principal investigator, Associate professor, Department of Anesthesiology and Pain Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04906889
- Sponsor's protocol ID
- dexmedetomidine-lidocaine
- Status last verified
- Jan 2023
- First submitted
- 25 May 2021
- Last updated
- 12 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Opioid-free Anesthesia Using Dexmedetomidine-lidocaine on Acute Postoperative Pain in Gynecological Laparoscopy
- ClinicalTrials.gov ID
- NCT04906889
- Acronym / sponsor ID
- dexmedetomidine-lidocaine
- Conditions
- Gynecologic Disease
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: financial protocol
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 May 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 28 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexmedetomidine-lidocaine | Experimental | Drug: Dexmedetomidine Hydrochloride, Drug: Lidocaine HydrochlorideThe study group receives the dexmedetomidine and lidocaine infusion with general anesthesia for gynecological laparoscopy. |
| remifentanil | Active comparator | Drug: Remifentanil HydrochlorideThe control group receives the remifentanil infusion with general anesthesia for gynecological laparoscopy |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients scheduled for elective gynecological laparoscopy
Key exclusion criteria (7 listed)
- emergent surgery
- cancer surgery
- chronic pain requiring pain killers
- psychiatric disease
- preoperative bradycardia (HR < 50 bpm)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexmedetomidine HydrochlorideAlso: precedexdexmedetomidine iv bolus for 10 minutes followed by the infusion of 0.1-1 ug/kg/h during general anesthesia | Drug | dexmedetomidine-lidocaine |
| Remifentanil HydrochlorideAlso: remifentanilremifentanil iv infusion of 0.5-5 ng/ml (effect site concentration using TCI) during general anesthesia | Drug | remifentanil |
| Lidocaine HydrochlorideAlso: lidocainelidocaine iv bolus followed by the infusion of 1.5mg/kg/h during general anesthesia | Drug | dexmedetomidine-lidocaine |
Primary outcome
postoperative pain in recovery room
Time frame: 30 minuetes after the completion of surgery
The pain level is assessed by using NRS (numeric rating scale; 0=no pain , 10=the worst pain)
2 secondary outcomes
shivering in recovery room
Time frame: 30 minuetes after the completion of surgery
postoperative nausea and vomiting (PONV)
Time frame: 30 minutes after the completion of surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Young Eun Moon, MD, PhD principal investigator
Associate professor, Department of Anesthesiology and Pain Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine Hydrochloride, Remifentanil Hydrochloride and Lidocaine Hydrochloride in people with Gynecologic Disease, run by The Catholic University of Korea at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain in recovery room (time frame: 30 minuetes after the completion of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2023.