Effect of Dexmedetomidine on Pain Due to Propofol Injection

NCT01463332 | Unknown DMC

• 2 other identifiers: SMC/CT/3/2011KVGMCH/CT/2/2011
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Pain; Intravenous Propofol Injection

Keywords

Propofol; Pain; Dexmedetomidine

Outcome Measures

Primary Outcomes (1)

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

  upto 24 hours

Secondary Outcomes (1)

• Incidence of Pain recall in postoperative recovery room

  Upto 24 hrs.

Study Arms (3)

Group NS

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.

Drug: I.V injection of 10 ml normal saline

Group D25

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.

Drug: I.V injection with 0.25mic/kg of dexmedetomidine

Group D50

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.

Drug: I.V injection of 0.50mic/kg of dexmedetomidine

Interventions

I.V injection of 10 ml normal saline DRUG

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.

Also known as: Group NS

Group NS

I.V injection with 0.25mic/kg of dexmedetomidine DRUG

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.

Also known as: dexmedetomidine

Group D25

I.V injection of 0.50mic/kg of dexmedetomidine DRUG

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.

Also known as: Dexmedetomidine

Group D50

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• KVG Medical College and Hospital: lead

MeSH Terms

Conditions

Pain

Interventions

Saline Solution; Dexmedetomidine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Shivakumar M C, MD

  KVG Medical College and Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 30, 2011
• First Posted: November 1, 2011
• Study Start: August 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: November 1, 2011

Record last verified: 2011-10