NCT04697745

Brief Summary

The main objective of our study is to evaluate analgesic effect of intrathecal dexamethasone and dexmedetomidine in elective caesarean sections

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
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

January 4, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 6, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2021

Completed
Last Updated

January 6, 2021

Status Verified

January 1, 2021

Enrollment Period

2 months

First QC Date

January 4, 2021

Last Update Submit

January 5, 2021

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

  • analgesic effect

    Duration of sensory block and time to first analgesic rescue . .

    Up to 24 hours after surgery

Secondary Outcomes (1)

  • intraoperative complications

    during surgery

Study Arms (2)

dexamethasone intrathecal

ACTIVE COMPARATOR
Drug: Intrathecal dexamethasone

dexmedetomidine intrathecal

ACTIVE COMPARATOR
Drug: Intrathecal dexmedetomidine

Interventions

Intrathecal dexamethasoneDRUG

intrathecal adjuvants to bupivacaine

dexamethasone intrathecal
Intrathecal dexmedetomidineDRUG

intrathecal adjuvants to bupivacaine

dexmedetomidine intrathecal

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • American Society of Anesthesiologists classII-III adult female patient (age :18 -40 years old )
  • Elective cesarean section under spinal anaesthesia
  • Gestational age \> 37 weeks
  • BMI less than 30 kg/m2

You may not qualify if:

  • Patient refusal
  • unable to give consent
  • age \< 18 or \> 40
  • BMI more than 30 kg/m2
  • known allergy to the study medication
  • coagulopathies or on anticoagulant medications
  • diabetic neuropathy
  • patients with psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 4, 2021

First Posted

January 6, 2021

Study Start

March 1, 2021

Primary Completion

April 30, 2021

Study Completion

May 30, 2021

Last Updated

January 6, 2021

Record last verified: 2021-01