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

May 8, 2023 updated by: Christina Lamontagne, St. Justine's Hospital

Dexmedetomidine Comme Adjuvant à la rachianesthésie Lors de césariennes électives : Une étude Pilote

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

52 patients will be recruted for this study, and will be randomized in two equal groups.

All the interventions carried out will be standardized. Medical care for patients will be the same as usual care, except for administration of dexmedetomidine or intrathecal narcotics.

In the test group, bupivacaine (12 mg, 1.6 ml) will be injected with 3 mcg of dexemedetomidine.

In the second group, bupivacaine (12 mg, 1.6 ml) will be injected with 100 mcg of morphine and 15 mcg of fentanyl with 0.25 ml of normal saline, which corresponds to the standard treatment.

The patients will receive standard analgesia, described in the protocol, post-operatively and will also have access to anti-nausea and anti-pruritics.

The patient will then be seen the day after surgery to collect her validated self-assessment scales for pain, nausea and vomiting, pruritus, chills and complete her QoR15 questionnaire.

This will be collected to establish preliminary data for a second study of non-inferiority for analgesia and gradation of side effects.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3T 1C5
        • Ste-Justine Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient will receive an elective c-section under spinal anesthesia
  • Gestational age > 37 weeks

Exclusion Criteria:

  • ASA score ≥ 3
  • Allergy or contraindication to receiving opioids (morphine or fentanyl)
  • Allergy or contraindication to receiving anti-inflammatory drugs (ketorolac, Naprosyn)
  • Allergy or contraindication to receiving acetaminophen
  • Height <152 cm or> 183 cm
  • Weight <50 or> 110 kg
  • Contraindication to spinal anesthesia
  • Conversion to general anesthesia
  • Combined spinal-epidural anesthesia
  • Inability to give informed consent, either secondary to a mental or physical disability or a significant language barrier (Inability to understand English or French)
  • Need for transfusion or other major complication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test group
Monitoring will be installed upon arrival.Metoclopramide 10 mg IV and Dexamethasone 4 mg will be given for nausea-prophylaxis. Patients may be given ondansetron 4 mg as rescue. Cefazoline 2G or clindamycin 900 mg will be given.A sterile spinal technique will be performed with a 25G Whitacre. Bupivacaine 12 mg (1.6 ml) will be drawn and given, along with dexmedetomidine 3 mcg (0.75 mL) previously blindly prepared for a total of 2.35 ml.Adequate blood pressure will be maintained with phenylephrine infusion or ephedrine IV. Glycopyrrolate 0.2 mg may be given for bradycardia.Once an adequate sensory block is obtained, the obstetrics team can perform the surgery.The patient will receive a dose of ketorolac 30 mg IV before leaving the PACU and then Naproxen 500 mg PO every 12 hours.She will receive acetaminophen 975 mg PO every 6 hours and hydromorphone 2-4 mg PO every 3 hours prn. Patients will also have access to a protocol for treatment of nausea and pruritus.
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.
Active Comparator: Control group
Monitoring will be installed upon arrival.Metoclopramide 10 mg IV and Dexamethasone 4 mg will be given for nausea-prophylaxis. Patients may be given ondansetron 4 mg as rescue. Cefazoline 2G or clindamycin 900 mg will be given.A sterile spinal technique will be performed with a 25G Whitacre. Bupivacaine 12 mg (1.6 ml) will be drawn and given, along with morphine 100 mcg, fentanyl 15 mcg and normal saline 0.25 ml previously blindly prepared for a total of 2.35 ml.Adequate blood pressure will be maintained with phenylephrine infusion or ephedrine IV. Glycopyrrolate 0.2 mg may be given for bradycardia.Once an adequate sensory block is obtained, the obstetrics team can perform the surgery.The patient will receive a dose of ketorolac 30 mg IV before leaving the PACU and then Naproxen 500 mg PO every 12 hours.She will receive acetaminophen 975 mg PO every 6 hours and hydromorphone 2-4 mg PO every 3 hours prn. Patients will also have access to a protocol for treatment of nausea and pruritus.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 3 study feasability
Time Frame: 3 months
The primary outcome will be to evaluate the phase 3 study feasability through recrutement rates and time needed to recrut a total of 52 patients
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioids consumption
Time Frame: 24 hours post-operatively
Total morphine equivalent consumed by the patient
24 hours post-operatively
Pruritus
Time Frame: 2, 6, 12 and 24 hours after surgery
Self-assessed validated numerical pruritus scale (NPS). Scale between 0 and 10, 10 being the worst symptoms the patient can imagine.
2, 6, 12 and 24 hours after surgery
Nausea
Time Frame: 2, 6, 12 and 24 hours after surgery
Absence or presence of nausea / vomiting at 2, 6, 12 and 24 hours after surgery
2, 6, 12 and 24 hours after surgery
Pain level
Time Frame: 2, 6, 12 and 24 hours after surgery
Self-assessed validated numerical pain scale (NPS).Scale between 0 and 10, 10 being the worst symptoms the patient can imagine.
2, 6, 12 and 24 hours after surgery
Quality of recovery and patient's satisfaction
Time Frame: 24 hours after surgery
Satisfaction according to the QoR15 questionnaire. Questionnaire containing 15 question to evaluate the quality of recovery in patients after a surgery.
24 hours after surgery
Nausea
Time Frame: 24 hours post-operatively
Number of anti-nausea medication doses needed
24 hours post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Justine's Hospital

Investigators

  • Study Director: Christina Lamontagne, Ste-Justine's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2022

Primary Completion (Actual)

January 20, 2023

Study Completion (Actual)

May 5, 2023

Study Registration Dates

First Submitted

October 17, 2021

First Submitted That Met QC Criteria

October 17, 2021

First Posted (Actual)

October 29, 2021

Study Record Updates

Last Update Posted (Actual)

May 9, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-3543

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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