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Completed

NCT Number: NCT05099055

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine 0.004 MG/ML [Precedex]

Drug

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

Opioids

Drug

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Opioids consumption

    Time frame: 24 hours post-operatively

    Total morphine equivalent consumed by the patient

  2. 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.

  3. 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

  4. 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.

  5. 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.

  6. Nausea

    Time frame: 24 hours post-operatively

    Number of anti-nausea medication doses needed

Sponsors and collaborators

Lead sponsor

St. Justine's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 29, 2021
Registry last updated
May 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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