NCT07395271

Brief Summary

To compare the duration of sensory and motor blockade produced by two different intrathecal doses of dexmedetomidine (5 µg and 10 µg) when added to hyperbaric bupivacaine in patients undergoing elective cesarean section

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2025

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 22, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2026

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2026

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 9, 2026

Completed
Last Updated

February 9, 2026

Status Verified

January 1, 2026

Enrollment Period

3 months

First QC Date

January 23, 2026

Last Update Submit

January 31, 2026

Conditions

Dexmedetomidine

Keywords

Dexmedetomidinespinal anesthesiacesarean sectionbupivacainesensory blockmotor block

Outcome Measures

Primary Outcomes (2)

  • Duration of sensory blockade

    Visual Analouge Scale (0 to 10)

    6 hrs

  • Duration of motor blockade

    Bromage Scale (1 to 5)

    6 hrs

Secondary Outcomes (2)

  • Hemodynamic parameters

    Till end of surgery

  • Hemodynamic parameters

    Till end of surgery

Study Arms (2)

Group A

ACTIVE COMPARATOR

Dexmedetomidine 5 mcg

Drug: Dexmedetomidine 5 mcg

Group B

ACTIVE COMPARATOR

Dexmedetomidine 10 mcg

Drug: Dexmedetomidine 10 mcg

Interventions

Dexmedetomidine 5 mcgDRUG

12.5 mg (2.5 mL) of 0.5% hyperbaric bupivacaine + 5 µg dexmedetomidine

Also known as: Dexmedetomidine 5mcg
Group A
Dexmedetomidine 10 mcgDRUG

12.5 mg (2.5 mL) of 0.5% hyperbaric bupivacaine + 10 µg dexmedetomidine

Also known as: Dexmedetomidine 10mcg
Group B

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Parturients aged 20-40 years
  • ASA physical status II
  • Scheduled for elective cesarean section
  • Ability to provide informed written consent

You may not qualify if:

  • ASA physical status III or higher
  • Emergency cesarean section
  • Previous labor analgesia
  • History of cardiovascular, neurological, or systemic disease
  • Contraindications to spinal anesthesia
  • Surgery duration exceeding 60 minutes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahria International Hospital

Rawalpindi, Punjab Province, 46220, Pakistan

Location

Related Publications (1)

  • Mowar A, Singh V, Pahade A, Karki G. Effect of three different doses of intrathecal dexmedetomidine on subarachnoid block: a prospective randomized double-blind trial. Anaesth. pain intensive care 2021;26(1):8-13; DOI:10.35975/apic.v26i1.1759

    RESULT

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • azher munir, mbbs

    Bahria International Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
UNKNOWN
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Postgraduate Resident

Study Record Dates

First Submitted

January 23, 2026

First Posted

February 9, 2026

Study Start

October 22, 2025

Primary Completion

January 21, 2026

Study Completion

January 21, 2026

Last Updated

February 9, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)