NCT05311722

Brief Summary

To study control of post spinal shivering in patients undergoing lower segment cesarean section using dexmedetomidine, tramadol and ketamine

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
71

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2022

Shorter than P25 for phase_3

Status
unknown

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

First Submitted

Initial submission to the registry

March 9, 2022

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 5, 2022

Completed
25 days until next milestone

Study Start

First participant enrolled

April 30, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2023

Completed
Last Updated

April 5, 2022

Status Verified

March 1, 2022

Enrollment Period

8 months

First QC Date

March 9, 2022

Last Update Submit

April 4, 2022

Conditions

Post-Surgical Complication

Outcome Measures

Primary Outcomes (1)

  • Assessment of post spinal shivering by observing grades of shivering

    Control of post spinal shivering dexmedetomidine, tramadol and ketamine for control of post spinal shivering.

    10 minutes

Study Arms (3)

Dexmedetomidine

EXPERIMENTAL

Inj.dexmedetomidine 0.5mcg/kg diluted in 10ml N/s given as iv infusion over 10 minutes

Drug: Dexmedetomidine

Ketamine

EXPERIMENTAL

Inj.ketamine 0.5mg/kg diluted in 10ml N/s given as iv infusion over 10 minutes

Drug: Ketamine

Tramadol

EXPERIMENTAL

Inj.tramadol 0.5mg/kg diluted in 10ml N/s given as iv infusion over 10 minutes

Drug: Tramadol

Interventions

DexmedetomidineDRUG

Inj dexmedetomidine, will be given in infusion over 10 mins and their effect on post spinal shivering will be assessed.

Dexmedetomidine
KetamineDRUG

Ketamine

Ketamine
TramadolDRUG

Tramadol

Tramadol

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsAll females with age between 18 -60
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Woman of age 18-60
  • Pregnant woman in outdoor patient department and emergency

You may not qualify if:

  • patient. with history of hypersensitivity to opioids,
  • ketamine or bupivacaine
  • History of cardiovascular disease,
  • Hypertension,
  • psychosis,
  • antepartum hemorrhage,
  • cord prolapse,
  • fetal distress

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

DexmedetomidineKetamineTramadol

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsCyclohexanolsHexanolsFatty AlcoholsAlcoholsDimethylaminesMethylaminesAminesLipids

Central Study Contacts

Obaid ur rehman Reman, Mbbs

CONTACT

03335817980drobaid_55@yahoo.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 3 drugs were given to patients
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 9, 2022

First Posted

April 5, 2022

Study Start

April 30, 2022

Primary Completion

December 31, 2022

Study Completion

February 20, 2023

Last Updated

April 5, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share