Effect of Dexmedetomidine on Pain Due to Propofol Injection

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by KVG Medical College and Hospital.
Recruitment status was  Active, not recruiting
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

September 30, 2011
October 31, 2011
August 2011
October 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01463332 on ClinicalTrials.gov Archive Site
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.

Same as current
Not Provided
Not Provided
 
Effect of Dexmedetomidine on Pain Due to Propofol Injection
Effect of Dexmedetomidine on Pain Due to Propofol Injection:A Randomised, Double-blind, Controlled Clinical Trial

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Pain
  • Intravenous Propofol Injection
  • 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
  • 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
  • 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
  • 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.
    Intervention: Drug: I.V injection of 10 ml normal saline
  • 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.
    Intervention: Drug: I.V injection with 0.25mic/kg of 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.
    Intervention: Drug: I.V injection of 0.50mic/kg of dexmedetomidine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
150
October 2011
October 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01463332
SMC/CT/3/2011, KVGMCH/CT/2/2011
Yes
Shivakumar M C, MD, KVG Medical College and Hospital
KVG Medical College and Hospital
Not Provided
Principal Investigator: Shivakumar M C, MD KVG Medical College and Hospital
KVG Medical College and Hospital
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP