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

NCT05099055 | Completed Phase 3 DMC

• 1 other identifier: 2022-3543
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Phase 3 study feasability

  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 Outcomes (6)

• Opioids consumption

  24 hours post-operatively

• Pruritus

  2, 6, 12 and 24 hours after surgery

• Nausea

  2, 6, 12 and 24 hours after surgery

• Pain level

  2, 6, 12 and 24 hours after surgery

• Quality of recovery and patient's satisfaction

  24 hours after surgery

Study Arms (2)

Test group

EXPERIMENTAL

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]

Control group

ACTIVE COMPARATOR

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

Interventions

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.

Test group

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Justine's Hospital: lead

Study Sites (1)

Ste-Justine Hospital

Montreal, Quebec, H3T 1C5, Canada

Location

Related Publications (39)

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MeSH Terms

Conditions

Agnosia

Interventions

Dexmedetomidine; Analgesics, Opioid

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Christina Lamontagne

  Ste-Justine's Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesioligist

Model Details: Pilot study for a phase 3 study.

Study Record Dates

• First Submitted: October 17, 2021
• First Posted: October 29, 2021
• Study Start: March 15, 2022
• Primary Completion: January 20, 2023
• Study Completion: May 5, 2023
• Last Updated: May 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)