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Effect of Dexmedetomidine on Pain Due to Propofol Injection

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Shivakumar M C, MD, KVG Medical College and Hospital
ClinicalTrials.gov Identifier:
NCT01463332
First received: September 30, 2011
Last updated: October 31, 2011
Last verified: October 2011
History of Changes
  Purpose

Propofol is commonly used IV anesthetic, it has been formulated in a concentration of 10 mg/ml in a fat emulsion consisting of 10% soybean oil (long-chain triglycerides). When used for anesthetic induction, propofol causes pain on injection in 28%-90% of patients. pain probably results from a direct irritant effect. Several methods have been used to reduce this pain. Lidocaine pretreatment has been commonly proposed to decrease propofol induced pain, but its failure rate is between 13-32%. Dexmedetomidine is highly selective alfa-2 adrenoreceptor agonist. Alpha-2 receptors are located on blood vessels where they inhibit norepinephrine release. Investigators, therefore, speculated that dexmedetomidine could attenuate the pain due to injection of propofol. Investigators conducted a study to determine the efficacy of dexmedetomidine in decreasing pain due to injection of propofol.


Condition Intervention
Pain
Intravenous Propofol Injection
 Drug: I.V injection of 10 ml normal saline
Drug: I.V injection with 0.25mic/kg of dexmedetomidine
Drug: I.V injection of 0.50mic/kg of dexmedetomidine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Dexmedetomidine on Pain Due to Propofol Injection:A Randomised, Double-blind, Controlled Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by KVG Medical College and Hospital:

Primary Outcome Measures:
  • Pain score after propofol injection [ Time Frame: upto 24 hours ] [ Designated as safety issue: No ]

    After injecting study drugs the pain score after propofol was assessed by using visual rating scale and given score according to severity of pain 0 = no pain,

    1. = mild pain or soreness,
    2. = moderate pain and
    3. = severe pain associated with facial grimacing, arm withdrawal, movement or both.


Secondary Outcome Measures:
  • Incidence of Pain recall in postoperative recovery room [ Time Frame: Upto 24 hrs. ] [ Designated as safety issue: No ]

    All patient were observed for 2-hrs in recovery room and were asked to recall if there was pain during injection of propofol in the recovery room and incidence of pain was graded as

    0-No recall of pain

    1-Recall of pain present.



Estimated Enrollment: 150
Study Start Date: August 2011
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Group NS
Patients were randomly assigned in to three groups of 50 each using a computer-generated table of random numbers. Patients Group NS were injected intravenously with 10 ml of normal saline before injection of propofol.
 Drug: I.V injection of 10 ml normal saline
Patients were randomly assigned in to three groups of 50 each using a computer-generated table of random numbers. Patients Group NS were injected intravenously with 10 ml of normal saline before injection of propofol.
Other Name: Group NS
Active Comparator: Group D25
Patients were randomly assigned in to three groups of 50 each using a computer-generated table of random numbers. Patients Group D25 were injected intravenously with 0.25mic/kg of dexmedetomidine diluted with normal saline into 10ml before injection of propofol.
 Drug: I.V injection with 0.25mic/kg of dexmedetomidine
Patients were randomly assigned in to three groups of 50 each using a computer-generated table of random numbers. Patients Group D25 were injected intravenously with 0.25mic/kg of dexmedetomidine diluted with normal saline into 10ml before injection of propofol.
Other Name: dexmedetomidine
Active Comparator: Group D50
Patients were randomly assigned in to three groups of 50 each using a computer-generated table of random numbers. Patients Group D50 were injected intravenously with 0.50mic/kg of dexmedetomidine diluted with normal saline into 10ml before injection of propofol.
 Drug: I.V injection of 0.50mic/kg of dexmedetomidine
Patients were randomly assigned in to three groups of 50 each using a computer-generated table of random numbers. Patients Group D50 were injected intravenously with 0.50mic/kg of dexmedetomidine diluted with normal saline into 10ml before injection of propofol.
Other Name: Dexmedetomidine

Detailed Description:

Propofol solution is fat emulsion consisting of soyabean oil. When used for anesthetic induction, propofol causes pain or discomfort on injection. Many factors appear to affect the incidence of pain, which includes site of injection, size of vein, speed of injection, buffering effect of blood, temperature and composition of propofol solution and concomitant use of drugs such as local anaesthetics and opiates.

Pain on injection of propofol can be immediate or delayed. Immediate pain probably results from a direct irritant effect whereas delayed pain probably results from an indirect effect via the kinin cascade. Delayed pain has latency of between 10 and 20 s. The pain produced is usually described as tingling, cold, or numbing, at its worst, a severe burning pain proximal to the site of injection. This sensation tends to occur within 10-20 s of injection and lasts only for the duration of injection. Despite this discomfort, the incidence of phlebitis is less than 1%.

Several methods have been used to reduce this pain with limited success. Lidocaine pretreatment is commonly used to decrease propofol induced pain, but its failure rate is between 13-32%.

Dexmedetomidine is an selective alfa-2 adrenoreceptor agonist with supraspinal, spinal, and peripheral actions. Alpha-2 receptors are located on blood vessels where they inhibit norepinephrine release. Investigators, therefore, speculated that dexmedetomidine could attenuate the pain due to injection of propofol.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA I & II
  • Both gender
  • Age 18-60
  • Elective surgery

Exclusion Criteria:

  • Patients taking sedatives or analgesics in the past 24 hours
  • History of allergic reactions to anesthetic drugs,
  • Atrio-ventricular conduction defects
  • Cardiovascular disease and
  • Pregnant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01463332

Sponsors and Collaborators
KVG Medical College and Hospital
Investigators
Principal Investigator: Shivakumar M C, MD KVG Medical College and Hospital
  More Information

No publications provided

Responsible Party: Shivakumar M C, MD, Assistant Professor, KVG Medical College and Hospital
ClinicalTrials.gov Identifier: NCT01463332     History of Changes
Other Study ID Numbers: SMC/CT/3/2011, KVGMCH/CT/2/2011
Study First Received: September 30, 2011
Last Updated: October 31, 2011
Health Authority: India: Ministry of Health

Keywords provided by KVG Medical College and Hospital:
Propofol
Pain
Dexmedetomidine

Additional relevant MeSH terms:
Propofol
Dexmedetomidine
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives
 Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013