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Clinical Trials/NCT01661803
NCT01661803
Completed
Not Applicable

Intrathecal Bupivacaine Versus Bupivacaine and Clonidine in Paediatrics Age Group:A Comparative Evaluation

ACPM Medical College0 sites60 target enrollmentNovember 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pediatric Spinal Anesthesia
Sponsor
ACPM Medical College
Enrollment
60
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

The investigators can summarize intrathecal clonidine can potentiate bupivacaine thereby bringing about better quality and longer duration of analgesia, better sedation and better postoperative outcomes with minimal side effects.

Detailed Description

In our Randomized controlled, double blind study involving 30 subjects in two groups; the investigators compared the safety, efficacy and quality of using intrathecal hyperbaric bupivacaine 0.5% and hyperbaric bupivacaine 0.5% with clonidine 1µg/kg in paediatric patients undergoing surgeries below T8 dermatome. American Society of Anesthesiologists (ASA) Grade I patients aged between 3-10 years were scheduled for the surgeries below T8 dermatome up to two hrs duration. The patients were randomly allocated in - Group A-who received 0.5%of hyperbaric Bupivacaine 0.4mg/kg for 5 to15 kg or 0.3 mg/kg for more than 15 kg intrathecally. Group B-who received 0.5%of hyperbaric Bupivacaine 0.4mg/kg for 5 to15 kg or 0.3 mg/kg for more than 15 kg and 1µg/kg preservative free clonidine intrathecally. The patients studied across the group did not vary much with respect to age, weight and sex distribution.

Registry
clinicaltrials.gov
Start Date
November 2009
End Date
January 2012
Last Updated
13 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
ACPM Medical College
Responsible Party
Principal Investigator
Principal Investigator

DR.NAGESH JAMBURE

resident,anesthesia department,a.c.p.m.medical college,dhule,maharashtra,india

ACPM Medical College

Eligibility Criteria

Inclusion Criteria

  • ASA grade-1 physical status.
  • weight 5-35kg
  • age-3 to 10 yrs

Exclusion Criteria

  • patients with known sensitivity to drugs to be used.
  • gross spinal deformity
  • patients in whom regional anesthesia is contraindicated.
  • patients with peripheral neuropathy.
  • patient with hemodynamic instability.

Outcomes

Primary Outcomes

Not specified

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