NCT03879564

Brief Summary

This is a randomized, double-blinded study to evaluate the analgosedative effect of ketamine in a surgical intensive care unit. The patients who will receive continuous fentanyl infusion for either pain control or sedation will be recruited in this trial. Fentanyl will be titrated with initial loading doses of 20 mcg until the numeral rating scale(NRS) less than 4 or critical care pain observation tool (CPOT) less than 3 or Richmond agitation sedation score (RASS) -2-0. Then the patients will be randomised in to receive saline infusion in control group (Group C) or ketamine infusion in ketamine group (Group K). Ketamine will be administered with an initial bolus of 0.3 mg/kg followed by a perfusion of1.5 mcg/kg/min during the first 48 h. The dose of fentanyl will be protocolized adjusted according to NRS or CPOT or RASS. We tested the research hypothesis that low-doseketamine infusion is associated with a reduced fentanyl dose without increased vulnerability to its psychotropic effects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
118

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2019

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 18, 2019

Completed
18 days until next milestone

Study Start

First participant enrolled

April 5, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

July 15, 2024

Status Verified

July 1, 2024

Enrollment Period

2.7 years

First QC Date

March 11, 2019

Last Update Submit

July 12, 2024

Conditions

Critically IllPain, Postoperative

Outcome Measures

Primary Outcomes (1)

  • fentanyl consumption

    the amount of fentanyl in microgram/kg in the patients who receive ketamine compare with who receive NSS

    24 hours after initial fentanyl infusion

Secondary Outcomes (11)

  • Psychomimetic adverse effects

    72 hours after admitted to ICU

  • Duration of mechanical ventilation

    30 days after admitted to ICU

  • ICU length of stay

    30 days after admitted to ICU

  • bowel motility

    72 hours after admitted to ICU

  • cardiovascular effect

    72 hours after admitted to ICU

  • +6 more secondary outcomes

Study Arms (2)

control

PLACEBO COMPARATOR

0.9% NaCl IV bolus 0.3 ml/kg then drip 0.09 ml/kg/hr

Drug: Normal saline

ketamine

EXPERIMENTAL

ketamine in NSS (1 mg/ml) IV bolus 0.3 ml/kg then drip 0.09 ml/kg/hr

Drug: Ketamine

Interventions

KetamineDRUG

ketamine in NSS (1 mg/ml) IV bolus 0.3 ml/kg then drip 0.09 ml/kg/hr

ketamine
Normal salineDRUG

NSS IV bolus 0.3 ml/kg then drip 0.09 ml/kg/hr

control

Eligibility Criteria

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

You may qualify if:

  • Older than 18 years.
  • Need ICU care
  • Need continuous iv fentanyl as an sedative of analgesia drug

You may not qualify if:

  • Pregnant women
  • Known allergy to ketamine
  • Severe cardiovascular disorders (ejection fraction\< 30%, acute myocardial infarction, decompensated heart failure, significant tachyarrhythmia)
  • Acute psychosis
  • coma patient
  • receive
  • Renal insufficiency (creatinine clearance \< 30 mL/min)
  • Unable to assess pain with either NRS or CPOT
  • Neurosurgery/ CVT patients/ trauma patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine Siriraj hospital

Bangkok Noi, Bangkok, 10700, Thailand

Location

Related Publications (1)

  • Kitisin N, Raykateeraroj N, Hemtanon N, Kamtip P, Thikom N, Azimaraghi O, Piriyapatsom A, Chaiwat O, Eikermann M, Wongtangman K. Effect of Low-Dose Ketamine Infusion in the Intensive Care Unit on Postoperative Opioid Consumption and Traumatic Memories After Hospital Discharge: A Randomized Controlled Trial. Anesth Analg. 2025 Sep 1;141(3):598-607. doi: 10.1213/ANE.0000000000007419. Epub 2025 Feb 5.

    PMID: 39908192DERIVED

MeSH Terms

Conditions

Critical IllnessPain, Postoperative

Interventions

KetamineSaline Solution

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPostoperative ComplicationsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
ketamine and normal saline will be filled in 50-ml syringe and will be administered in the same condition
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

March 11, 2019

First Posted

March 18, 2019

Study Start

April 5, 2019

Primary Completion

December 30, 2021

Study Completion

June 30, 2024

Last Updated

July 15, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)