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NCT06418308 · ClinicalTrials.gov registry record · Phase 4

Intrathecal Dexmedetomidine vs Epinephrine

A Phase 4 study of Cesarean Section and Anesthesia, Spinal, sponsored by Icahn School of Medicine at Mount Sinai.

Recruiting
Registry status
Phase 4
Development phase
62
Enrollment target
1
Study location

NCT06418308: Recruiting Phase 4 study of Cesarean Section and Anesthesia, Spinal, sponsored by Icahn School of Medicine at Mount Sinai.

NCT06418308 is a Phase 4 study of Cesarean Section and Anesthesia, Spinal that is actively recruiting participants, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 62 participants, below the 166-participant average among 14 other Cesarean Section trials with a reported enrollment target (63% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06418308, a Phase 4 study of Cesarean Section and Anesthesia, Spinal, is actively recruiting participants, sponsored by Icahn School of Medicine at Mount Sinai.

RECRUITING
Registry status
Phase 4
Development phase
62 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

Investigate the efficacy of intrathecal epinephrine versus dexmedetomidine as adjuvant agents in cesarean section. Once the sensory block to pinprick has receded to a T10 level, the spinal is no longer as effective for surgical level pain relief. This is a measure of the duration of the spinal as an effective analgesic. Sensory recovery will be a T10 level. This will be measured in minutes.

Interventions

  • DRUG Epinephrine
  • DRUG Dexmedetomidine
  • DRUG Standardized Spinal Mixture

Study Locations (1)

New York

  • Mount Sinai Hospital - New York

Trial Details

FieldValue
Enrollment Target 62 participants
Start Date 2024-09-17
Est. Completion 2026-03
Phase Phase 4

What NCT06418308 shows while recruiting

NCT06418308 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 166-participant average among 14 other Cesarean Section trials with a reported enrollment target (63% lower).

The record links to 2 conditions, with Cesarean Section appearing as the primary indexed condition, and to 3 interventions - of which Epinephrine is the first listed.

NCT06418308 reports a single indexed study location in New York.

Frequently Asked Questions

What is clinical trial NCT06418308 about?

NCT06418308 is a clinical study titled "Intrathecal Dexmedetomidine vs Epinephrine". 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 adjunc...

What is the current status of trial NCT06418308?

This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 62 participants. The study started on 2024-09-17. Estimated completion is 2026-03.

What conditions does trial NCT06418308 study?

This clinical trial studies the following conditions: Cesarean Section, Anesthesia, Spinal.

What interventions are being tested in trial NCT06418308?

The interventions under investigation include: Epinephrine (DRUG), Dexmedetomidine (DRUG), Standardized Spinal Mixture (DRUG).

Who is sponsoring clinical trial NCT06418308?

This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06418308 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Cesarean Section

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06418308's enrollment target sits among peer trials

62 11th of 14 higher than 4 of 14 other Cesarean Section trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Cesarean Section trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06418308, the US trial registry maintained by the National Library of Medicine. NCT06418308 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.