Intrathecal Dexmedetomidine vs Epinephrine

Cesarean Section Clinical Trial

Official title:

Comparison of Intrathecal Epinephrine Versus Dexmedetomidine as Adjuvants in Cesarean Section

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06418308
• Other study ID #: STUDY-23-01613
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: May 2024
• Est. completion date: May 2025

Study information

• Verified date: May 2024
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Talia Scott, MD
• Phone: 720-212-7448
• Email: talia.scott[@]mountsinai.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Several studies have shown that adding dexmedetomidine or epinephrine to single-dose spinal analgesia preparations improves the length and/or speed of onset of the sensory block and post-operative pain management without increased negative side effects. To date, however, no study has compared adjunctive intrathecal dexmedetomidine to adjunctive intrathecal epinephrine in single-dose spinal analgesia. The purpose of this study is to determine if adjunctive intrathecal dexmedetomidine is non-inferior to adjunctive intrathecal epinephrine in providing better single-dose spinal analgesia during cesarean section.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pregnant patients aged 18-55 years who are presenting for scheduled cesarean section and are candidates for single shot spinal anesthesia for cesarean section.

Exclusion Criteria:

• Patient refusal of spinal anesthetic

• If patient is not a candidate for spinal anesthesia due to history of coagulopathy, elevated intracranial pressure, infection at site of injection, etc.

• Emergency cesarean section

• Preexisting motor or sensory deficit

• Suspected pre-eclampsia

• Patient receiving combined spinal-epidural as anesthetic technique

Related Conditions & MeSH terms

• Anesthesia, Spinal
• Cesarean Section

Intervention

Drug:
• Dexmedetomidine
5 mcg of dexmedetomidine
• Epinephrine
200 mcg of epinephrine
• Standardized Spinal Mixture
Standardized spinal mixture of 10.25 mg hyperbaric bupivacaine, 12.5 mcg fentanyl, and 0.125 mg morphine.

Locations

Country	Name	City	State
United States	Mount Sinai Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time required for sensory recovery at T10	Time required for sensory recovery at T10 to investigate the efficacy of adjuvant agents in cesarean section. Once the sensory block has receded to a T10 level, the spinal is no longer as effective for surgical level anesthesia. This will be measured in minutes.	360 minutes
Secondary	Time to motor and sensory recovery	Time to motor recovery determines how long the patient will be in the post anesthesia care unit.	480 minutes
Secondary	Time to sensory recovery	The speed of sensory regression determines how long the spinal will be effective.	480 minutes
Secondary	Time to administration of postoperative analgesic	The time to first postoperative analgesic gives information on how adequately pain is controlled postoperatively.	24 hours
Secondary	Number of participants receiving intravenous opioid	The use of intravenous opioid agents such as fentanyl or morphine during the cesarean section can demonstrate that the spinal is not adequate for surgical anesthesia and analgesia. Any use of intravenous opioid administered during cesarean section is indicative of inadequate analgesia and the number of participants receiving this will be reported	360 minutes
Secondary	Time required to achieve T4 anesthetic level	The onset time of the block can determine its feasibility in urgent situations where there is a time limit in which the surgeon must begin the operation.	60 minutes
Secondary	Incidence of specific side effects	Incidence of intraoperative hypotension, nausea, vomiting, shivering, and pruritis. Unfavorable side effects should be assessed as they affect patient experience. These are potential side effects from the spinal anesthesia itself and the normal mixture of bupivacaine, morphine, and fentanyl.	360 minutes