NCT07332572

Brief Summary

To compare the mean time of cessation of post-operative shivering after receiving intravenous dexmedetomidine versus tramadol in patients undergoing caesarean delivery under spinal anaesthesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2025

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 30, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 12, 2026

Completed
Last Updated

January 12, 2026

Status Verified

December 1, 2025

Enrollment Period

6 months

First QC Date

December 30, 2025

Last Update Submit

December 30, 2025

Conditions

Shivering Caused by Spinal Anesthesia

Keywords

Shivering

Outcome Measures

Primary Outcomes (1)

  • SHIVERING TIME

    Will assess the cessation time between two groups

    6 months

Study Arms (2)

Tramadol group

ACTIVE COMPARATOR

Tramadol

Drug: TramadolDrug: Dexmedetomidine

Dexmedetomidine group

ACTIVE COMPARATOR

Dexmedetomedine group

Drug: TramadolDrug: Dexmedetomidine

Interventions

TramadolDRUG

Comparative study of tramadol with dexmedetomedine

Dexmedetomidine groupTramadol group
DexmedetomidineDRUG

comparative study of tramadol and dexmed

Dexmedetomidine groupTramadol group

Eligibility Criteria

Age25 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemales who are pregnant
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant
  • Grade 3 or 4 Shivering

You may not qualify if:

  • Hypothyroidism
  • Known allergies to drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liaquat National Hospital

Karachi, Sindh, 75780, Pakistan

Location

MeSH Terms

Interventions

TramadolDexmedetomidine

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsDimethylaminesMethylaminesAminesLipidsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Shavez Noor

Study Record Dates

First Submitted

December 30, 2025

First Posted

January 12, 2026

Study Start

June 1, 2025

Primary Completion

December 1, 2025

Study Completion

December 15, 2025

Last Updated

January 12, 2026

Record last verified: 2025-12

Locations

PA(1)