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Dexmedetomidine for Pregnancy

Phase 2
Waitlist Available
Research Sponsored by Grace Lim, MD, MS
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up first 120 minutes of analgesia
Awards & highlights

Study Summary

This trial is testing which pain medication is best for labor analgesia.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first 120 minutes of analgesia
This trial's timeline: 3 weeks for screening, Varies for treatment, and first 120 minutes of analgesia for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pain Burden, AUC (30 minutes)
Secondary outcome measures
Pain Burden, AUC (120 minutes)
Pain Scores (30 minutes)

Side effects data

From 2020 Phase 4 trial • 798 Patients • NCT02004613
57%
Clinically important hypotension
9%
Clinically important bradycardia
1%
infection
1%
stroke
1%
Atelectasis
1%
Hemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Dexmedetomidine

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: DexmedetomidineExperimental Treatment2 Interventions
Bolus dose at epidural initiation, through the epidural catheter: 10 ml Ropivacaine 0.1 % combined with a single dose of Dexmedetomidine 30 mcg
Group II: ClonidineExperimental Treatment2 Interventions
Bolus dose at epidural initiation, through the epidural catheter: 10 ml Ropivacaine 0.1 % combined with a single dose of Clonidine 60 mcg
Group III: Ropivacaine + FentanylActive Control2 Interventions
Bolus dose at epidural initiation, through the epidural catheter: 10 ml Ropivacaine 0.1 % combined with a single dose of Fentanyl 100mcg
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Clonidine
2010
Completed Phase 4
~1890
Dexmedetomidine
2015
Completed Phase 4
~1980
Ropivacaine
2017
Completed Phase 4
~1960

Find a Location

Who is running the clinical trial?

Grace Lim, MD, MSLead Sponsor
8 Previous Clinical Trials
525 Total Patients Enrolled

Media Library

Dexmedetomidine Clinical Trial Eligibility Overview. Trial Name: NCT05487196 — Phase 2
Pregnancy Research Study Groups: Clonidine, Dexmedetomidine, Ropivacaine + Fentanyl
Pregnancy Clinical Trial 2023: Dexmedetomidine Highlights & Side Effects. Trial Name: NCT05487196 — Phase 2
Dexmedetomidine 2023 Treatment Timeline for Medical Study. Trial Name: NCT05487196 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment open to participants aged 45 and beyond?

"This trial has a specific age range of 18 to 65 as criteria for enrolment. There are also smaller trials available people younger than 18 and older than 65, with 24 studies targeting minors and 86 focusing on seniors."

Answered by AI

Has the FDA sanctioned Dexmedetomidine for use?

"Although there is some evidence of safety, due to the fact that this study is only in its second phase, no efficacy data exists. Hence our team assigned dexmedetomidine a rating of 2 on a scale from 1-3."

Answered by AI

How many individuals are participating in this medical experiment?

"Affirmative, according to clinicaltrials.gov this trial is presently recruiting participants, having gone live on September 28th 2022 and receiving its latest update on November 1st 2022. The study requires 160 patients at a single location."

Answered by AI

To what demographic is this clinical trial open?

"This study is accepting up to 160 pregnant candidates aged 18-65. Those who meet these criteria are eligible for the trial."

Answered by AI

Are there opportunities for participation in this experiment currently available?

"Affirmative. Clinicaltrials.gov attests that this clinical trial, which was initially advertised on September 28th 2022, is currently recruiting participants. Approximately 160 people need to be recruited from 1 medical centre."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Effectiveness of Clonidine, Dexmedetomidine, and Fentanyl Adjuncts for Labor Epidural Analgesia
Grace Lim, MD, MS 2022. "Effectiveness of Clonidine, Dexmedetomidine, and Fentanyl Adjuncts for Labor Epidural Analgesia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05487196.
~35 spots leftby Apr 2025
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