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Trial record 14 of 840 for:    Ketamine

Ketamine Reduces Tourniquet Pain In Patients Undergoing Lower Limb Surgery Under Spinal Anaesthesia

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ClinicalTrials.gov Identifier: NCT03357055
Recruitment Status : Not yet recruiting
First Posted : November 29, 2017
Last Update Posted : December 13, 2017
Sponsor:
Information provided by (Responsible Party):
Dr Foo Li Lian, University of Malaya

Brief Summary:

A prospective, double blind, randomised controlled trial to evaluate the effect of ketamine in reducing tourniquet pain for patients undergoing lower limb surgery under spinal anaesthesia.

Secondary Objective To evaluate the effect of ketamine in attenuating TIH for patients undergoing lower limb surgery under spinal anaesthesia.


Condition or disease Intervention/treatment Phase
Tourniquet Pain Drug: Ketamine Drug: Normal saline Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Ketamine Reduces Tourniquet Pain In Patients Undergoing Lower Limb Surgery Under Spinal Anaesthesia
Estimated Study Start Date : December 13, 2017
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: Ketamine arm
Ketamine group will receive an IV infusion of 0.25mg/kg of ketamine in a 10 ml syringe over 10 minutes starting 10 minutes before pneumatic tourniquet inflation. Throughout the procedure patients will receive 0.25mg/kg of ketamine infusion at 10ml/hour until the end of operation.
Drug: Ketamine
IV infusion of 0.25mg/kg of ketamine over 10 minutes before pneumatic tourniquet inflation. Throughout procedure patient will receive 0.25mg/kg of ketamine infusion.

Placebo Comparator: Control arm
Control group will receive an intravenous (IV) infusion of 10 ml of normal saline in a 10 ml syringe over 10 minutes starting 10 minutes before pneumatic tourniquet inflation. Throughout the procedure, patients will receive 10ml/hour normal saline infusion until the end of operation.
Drug: Normal saline
Control group will receive an intravenous (IV) infusion of 10 ml of normal saline in a 10 ml syringe over 10 minutes starting 10 minutes before pneumatic tourniquet inflation. Throughout the procedure, patients will receive 10ml/hour normal saline infusion until the end of operation




Primary Outcome Measures :
  1. Change in pain scores among patients in ketamine group vs patients in saline group, for patients undergoing lower limb surgery under spinal anaesthesia. [ Time Frame: Pain scores will be assessed at baseline and throughout tourniquet application, at 10 minute intervals until 10 minutes after tourniquet deflation. ]
    Pain Score of 10-30mm: Mild pain Pain Score of 40-60mm: Moderate pain Pain Score of 70-100mm: Severe pain


Secondary Outcome Measures :
  1. Change in blood pressure in ketamine group vs saline group, for patients undergoing lower limb surgery under spinal anaesthesia. [ Time Frame: SBP, DBP, MAP and HR will be assessed at baseline and throughout tourniquet application, at 10 minute intervals until 10 minutes after tourniquet deflation ]
    Systolic, Diastolic blood pressure, Mean arterial pressure, heart rate



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. ASA I or II 2. Age between 18-65 years old undergoing lower limb surgeries under spinal anaesthesia with pneumatic tourniquet inflation time more than 60 minutes

Exclusion Criteria:

  • 1. Allergic to ketamine 2. Patients who have any degree of heart block, cardiovascular diseases, uncontrolled hypertension, severe peripheral vascular disease, sickle cell disease, diabetes neuropathy, deep vein thrombosis and pulmonary embolism, liver and renal impairment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03357055


Contacts
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Contact: Li Lian Foo +60379492052 li_lian@ummc.edu.my
Contact: Chew Yin Wang +60379492052

Sponsors and Collaborators
Dr Foo Li Lian
Investigators
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Principal Investigator: Li Lian Foo Anaesthesiologist, Department of Anaesthesia, University Malaya Medical Centre

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Responsible Party: Dr Foo Li Lian, Anaesthesiologist, University of Malaya
ClinicalTrials.gov Identifier: NCT03357055     History of Changes
Other Study ID Numbers: NMRR-17-2459-34013.
First Posted: November 29, 2017    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr Foo Li Lian, University of Malaya:
tourniquet, pain, ketamine

Additional relevant MeSH terms:
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Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action