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Dexmedetomine as Adjuvant for Spinal Anesthesia in Elective Cesarian Sections : a Pilot Study

NCT05099055 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2023-05-09

No results posted yet for this study

Summary

The proposed pilot study is a prospective, randomized, controlled, double-blind, single-center pilot study.The aim of this pilot project is to evaluate the feasibility of a phase III study on the use of dexmedetomidine in intrathecal in the context of elective cesarean section.

The target population for the study will be adult pregnant women undergoing elective cesarean section under spinal anesthesia. This study will be carried out at a single site, the CHU Sainte-Justine as part of a research internship as part of the anesthesiology residency program at the University of Montreal.

Conditions

  • Analgesia
  • Analgesics, Opioid
  • Anesthesia, Obstetrical
  • Anesthesia, Spinal
  • Analgesics, Non-Narcotic
  • Dexmedetomidine
  • Analgesia, Obstetrical

Interventions

DRUG

Dexmedetomidine 0.004 MG/ML [Precedex]

Injection of 3 mcg of dexmedetomidine and 12 mg of bupivacaine in the intrathecal space to provide spinal anesthesia.

DRUG

Opioids

Injection of 100 mcg of morphine, 15 mcg of fentanyl and 0.25 ml of normal salin (sterile) with 12 mg of bupivacaine in the intrathecal space to provide spinal anesthesia.

Sponsors & Collaborators

  • St. Justine's Hospital

    lead OTHER

Principal Investigators

  • Christina Lamontagne · Ste-Justine's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-15
Primary Completion
2023-01-20
Completion
2023-05-05

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05099055 on ClinicalTrials.gov