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

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05099055
• Other study ID #: 2022-3543
• Status: Completed
• Phase: Phase 3
• Start date: March 15, 2022
• Est. completion date: May 5, 2023

Study information

• Verified date: May 2023
• Source: St. Justine's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: May 5, 2023
• Est. primary completion date: January 20, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Ste-Justine Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
St. Justine's Hospital

Country where clinical trial is conducted

Canada, 

References & Publications (39)

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* Note: There are 39 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Opioids consumption	Total morphine equivalent consumed by the patient	24 hours post-operatively
Secondary	Pruritus	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
Secondary	Nausea	Absence or presence of nausea / vomiting at 2, 6, 12 and 24 hours after surgery	2, 6, 12 and 24 hours after surgery
Secondary	Pain level	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
Secondary	Quality of recovery and patient's satisfaction	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
Secondary	Nausea	Number of anti-nausea medication doses needed	24 hours post-operatively