NCT04259476

Brief Summary

Low dose perioperative ketamine infusion and it's effect on postoperative pain score, sedation score and narcotic consumption in patients undergoing spine surgery: A prospective randomized double blind control trial.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2020

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 4, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 6, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

February 6, 2020

Status Verified

February 1, 2020

Enrollment Period

5 months

First QC Date

February 4, 2020

Last Update Submit

February 5, 2020

Conditions

for Post-operative Pain Relief in Spine Surgeries

Keywords

post-operative analgesia, ketamine, multi-modal therapy

Outcome Measures

Primary Outcomes (1)

  • post operative pain score

    visual analogue scoring will be done for 24 hours post-operatively

    upto 24 hours

Study Arms (2)

group A

ACTIVE COMPARATOR

WIll be given low dose perioperative ketamine infusion, as well as a ketamine bolus at start of surgery.

Drug: Ketamine Hydrochloride

group B

PLACEBO COMPARATOR

will be given normal saline infusion and bolus at start of surgery.

Drug: Ketamine Hydrochloride

Interventions

Ketamine HydrochlorideDRUG

low dose perioperative ketamine infusion. and its effects on post-operative pain.

Also known as: placebo, normal saline intrathecally.
group Agroup B

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- A total of 60 adult patients aged between 18 and 60 years old with American Society of Anesthesiology (ASA) physical status I-II scheduled for elective spine surgery

You may not qualify if:

  • BMI more than 40 kg/m2
  • poorly controlled arterial hypertension (blood pressure higher than 140/90 mmHg)
  • respiratory, liver or kidney disease
  • heart disease (heart block or myocardial ischemia)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Services Institute of Medical Sciences

Lahore, Punjab Province, 042, Pakistan

RECRUITING

MeSH Terms

Interventions

Ketamine

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Central Study Contacts

sana siddiq, FCPS

CONTACT

00923343368803dr.sana.wasiq@hotmail.com

naila asad, fcps

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
double blind
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: randomized control trial
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

February 4, 2020

First Posted

February 6, 2020

Study Start

January 1, 2020

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

February 6, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)