Overview

This trial is active, not recruiting.

Conditions pain, intravenous propofol injection
Treatments i.v injection of 10 ml normal saline, i.v injection with 0.25mic/kg of dexmedetomidine, i.v injection of 0.50mic/kg of dexmedetomidine
Sponsor KVG Medical College and Hospital
Start date August 2011
End date October 2011
Trial size 150 participants
Trial identifier NCT01463332, KVGMCH/CT/2/2011, SMC/CT/3/2011

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Placebo Comparator)
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.
i.v injection of 10 ml normal saline 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.
(Active Comparator)
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.
i.v injection with 0.25mic/kg of dexmedetomidine 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.
(Active Comparator)
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.
i.v injection of 0.50mic/kg of dexmedetomidine 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.

Primary Outcomes

Measure
Pain score after propofol injection
time frame: upto 24 hours

Secondary Outcomes

Measure
Incidence of Pain recall in postoperative recovery room
time frame: Upto 24 hrs.

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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

Additional Information

Official title Effect of Dexmedetomidine on Pain Due to Propofol Injection:A Randomised, Double-blind, Controlled Clinical Trial
Principal investigator Shivakumar M C, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2011.
Information provided to ClinicalTrials.gov by KVG Medical College and Hospital.