NCT04545801

Brief Summary

In this prospective randomized trial, investigators compared the analgesic effect of subanesthetic dose of ketamine versus placebo in parturients undergoing cesarean section under spinal anesthesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

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

January 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 4, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 11, 2020

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

3 months

First QC Date

September 4, 2020

Last Update Submit

September 12, 2020

Conditions

Cesarean SectionPostoperative Pain

Outcome Measures

Primary Outcomes (1)

  • Dynamic Visual Analog Scale

    Pain score VAS range from 0 to 10, high scores mean worse outcome

    24 hours after cesarean section

Study Arms (2)

Ketamine Group

ACTIVE COMPARATOR

Patients recieving 0.25 mg/kg of ketamine 5 minutes after spinal anesthesia

Drug: 0.25 mg/kg of Ketamine

Placebo Group

PLACEBO COMPARATOR
Drug: 20ml of normal saline solution

Interventions

0.25 mg/kg of KetamineDRUG

patients will recieve 0.25mg/kg of ketamine intravenously 5 min after spinal anesthesia

Ketamine Group
20ml of normal saline solutionDRUG

20ml of normal saline solution intravenously 5 minutes after spinal anesthesia

Placebo Group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsincluding only female patients undergoing cesarean section
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • full term pregnant adult patients
  • Monofetal pregnancy
  • scheduled for urgent or elective cesarean section under spinal anesthesia

You may not qualify if:

  • necessity of general anesthesia during the procedure
  • Post partum hemorrage

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mongi Slim University Hospital

La Marsa, Tunis Governorate, 2046, Tunisia

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, head of department of anesthesia and critical care

Study Record Dates

First Submitted

September 4, 2020

First Posted

September 11, 2020

Study Start

January 1, 2019

Primary Completion

March 31, 2019

Study Completion

April 30, 2019

Last Updated

September 16, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)