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

St. Justine's Hospital

Status and phase: Completed; Phase 3

Conditions: Analgesia, Obstetrical; Analgesics, Opioid; Dexmedetomidine; Analgesics, Non-Narcotic; Anesthesia, Spinal; Analgesia; Anesthesia, Obstetrical

Treatments: Drug: Opioids; Drug: Dexmedetomidine 0.004 MG/ML [Precedex]

Study type: Interventional

Funder types: Other

Identifiers

NCT05099055

2022-3543

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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42 participants in 2 patient groups

Test group

Experimental group

Description:

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.

Treatment:

Drug: Dexmedetomidine 0.004 MG/ML [Precedex]

Control group

Active Comparator group

Description:

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.

Treatment:

Drug: Opioids