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.

Study Overview

• Status: Unknown
• Conditions: Pain; Intravenous Propofol Injection
• Intervention / Treatment: 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

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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: 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 Names: Dexmedetomidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score after propofol injection	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,; = mild pain or soreness,; = moderate pain and; = severe pain associated with facial grimacing, arm withdrawal, movement or both.	upto 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Pain recall in postoperative recovery room	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.	Upto 24 hrs.

Collaborators and Investigators

• Sponsor: KVG Medical College and Hospital
• Investigators: Principal Investigator: Shivakumar M C, MD, KVG Medical College and Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Anticipated): October 1, 2011
• Study Completion (Anticipated): October 1, 2011

Study Registration Dates

• First Submitted: September 30, 2011
• First Submitted That Met QC Criteria: October 31, 2011
• First Posted (Estimate): November 1, 2011

Study Record Updates

• Last Update Posted (Estimate): November 1, 2011
• Last Update Submitted That Met QC Criteria: October 31, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: Pain; Propofol; Dexmedetomidine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: SMC/CT/3/2011; KVGMCH/CT/2/2011 (Other Identifier: KVG Medical college and hospital)