NCT07465185

Brief Summary

Cesarean section (CS) is one of the most frequently performed surgical procedures globally, with an increasing demand for safe and effective anesthesia techniques. Regional anesthesia, particularly intrathecal anesthesia, has become the method of choice for elective cesarean deliveries.The most commonly used local anesthetic for intrathecal anesthesia is bupivacaine.Recent studies have focused on adjunctive agents to enhance the efficacy of local anesthetics.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_2

Timeline
5mo left

Started Mar 2026

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress32%
Mar 2026Oct 2026

First Submitted

Initial submission to the registry

February 27, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 11, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

March 15, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2026

Last Updated

March 11, 2026

Status Verified

February 1, 2026

Enrollment Period

6 months

First QC Date

February 27, 2026

Last Update Submit

March 9, 2026

Conditions

Anesthesia

Keywords

bupivacainedexmetomedinespinal anesthesiacessarian delivery

Outcome Measures

Primary Outcomes (1)

  • the duration of sensory block

    time taken from intrathecal injection to sensory regression to S1 dermatome.

    after anesthesia up to 12 hours postoperatively

Secondary Outcomes (3)

  • the onset time of sensory block

    during 30 minutes after intrathecal injection

  • the onset time of motor block

    during 30 minutes after intrathecal injection

  • The recovery quality of parturients

    24 hours post-operatively

Study Arms (2)

Group (B)

ACTIVE COMPARATOR

will receive intra-thecal hyperbaric bupivacaine 11 mg(2.2 ml) of 0.5% bupivacaine, with 0.5 ml of normal saline in total volume 2.5 ml.

Drug: Bupivacaine

Group (BD)

ACTIVE COMPARATOR

will receive 9 mg (1.8 ml) of 0. 5% bupivacaine, with 5 μg of DEX in 0.5ml of normal saline in total volume 2.5 ml.

Drug: Bupivacaine and Dexmedetomidine

Interventions

BupivacaineDRUG

patient will receive intra-thecal hyperbaric bupivacaine 11 mg(2.2 ml) of 0.5% bupivacaine, with 0.5 ml of normal saline in total volume 2.5 ml.

Group (B)
Bupivacaine and DexmedetomidineDRUG

patient will receive 9 mg (1.8 ml) of 0. 5% bupivacaine, with 5 μg of DEX in 0.5ml of normal saline in total volume 2.5 ml.

Group (BD)

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • (1) Full-term pregnant women undergoing elective cesarean section under spinal anesthesia. (2) Age: 20 \~ 35 years. (3) ASA physical status II \~ III

You may not qualify if:

  • Multiple pregnancies.
  • Cardiovascular disease(e.g., pre-eclampsia and hypertension).
  • Serious hepatic dysfunction (Child-Pugh class C).
  • serious renal dysfunction (undergoing dialysis before surgery).
  • History of alcohol or opioid addiction.
  • Contraindication to spinal anesthesia.
  • Refusing to sign informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Banha Faculity of Medicine

Banhā, Elqalyoubea,, 13511, Egypt

RECRUITING

MeSH Terms

Interventions

BupivacaineDexmedetomidine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

fatma ahmed abdelfatah, MD

CONTACT

00201091921540drfatmaahmed86@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

February 27, 2026

First Posted

March 11, 2026

Study Start

March 15, 2026

Primary Completion (Estimated)

September 15, 2026

Study Completion (Estimated)

October 15, 2026

Last Updated

March 11, 2026

Record last verified: 2026-02

Locations

EG(1)