Comparison of Different Doses of Clonidine to Fentanyl as an Adjuvant to Bupivacaine 0.5% for Spinal Anesthesia

NCT01205204 | Withdrawn DMC

• 1 other identifier: abcd123
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the safety, quality and duration of block with the addition of Clonidine in different doses to 0.5% heavy bupivacaine, and to compare it with addition of Fentanyl to 0.5% heavy bupivacaine in sub- arachnoid block.

Conditions

Full Term Pregnant Patients; Undergoing Lower Segment Caesarian Section

Keywords

Clonidine; Fentanyl; Bupivacaine; Spinal Anesthesia; Lower Segment Caesarian Section

Outcome Measures

Primary Outcomes (1)

• Duration of block

  Measured by regression of sensory block by 2 dermatomal segments and residual motor blockade monitored by wearing off time (when patient starts to lift legs against gravity)

  6 hours

Secondary Outcomes (6)

• Demographic characteristics

  15 Minutes

• Maternal safety

  24 Hours

• Maternal side effects

  24 hours

• Foetal safety

  20 Minutes

• Quality of block

  15 Minutes

Study Arms (4)

BF25 (Control)

ACTIVE COMPARATOR

GROUP BF25 (CONTROL) In this group, patient will be given 2.0 mL of hyperbaric bupivacaine 0.5% with 25 mcg of fentanyl, intrathecally.

Drug: Fentanyl

BC15(Study 1)

EXPERIMENTAL

GROUP BC15 In this group, patient will be given 2.0 mL of hyperbaric bupivacaine 0.5%with15 mcg of clonidine, intrathecally.

Drug: Clonidine

BC30(Study 2)

EXPERIMENTAL

GROUP BC30 In this group, patient will be given 2.0 mL of hyperbaric bupivacaine 0.5% with 30 mcg of clonidine, intrathecally.

Drug: Clonidine

BC60 (Study 3)

EXPERIMENTAL

GROUP BC60 In this group, patient will be given 2.0 mL of hyperbaric bupivacaine 0.5% with 60 mcg of clonidine, intrathecally.

Drug: clonidine

Interventions

Fentanyl DRUG

GROUP BF25 (CONTROL) In this group, patient will be given 2.0 mL of hyperbaric bupivacaine 0.5% with 25 mcg of fentanyl, intrathecally.

BF25 (Control)

clonidine DRUG

In this group, patient will be given 2.0 mL of hyperbaric bupivacaine 0.5%with15 mcg of clonidine, intrathecally.

BC15(Study 1)

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Undergoing Lower Segment Caesarian Section
• ASA grade I or II
• Not having any complicated pregnancy
• Not having any systemic disorders.
• Age group 20 - 35 years

You may not qualify if:

• Not willing for spinal anaesthesia
• Unwilling to get enrolled in this study.
• Complicated pregnancy like pregnancy induced hypertension, placenta previa, abruptio placenta.
• Systemic disorders like diabetes, heart disease, chronic hypertension, pulmonary disease
• With acute fetal distress.
• With bleeding or coagulation disorders.
• Maternal haemorrhage leading to hypovolemia.
• Height less than 145 cms

Sponsors & Collaborators

• Pravara Institute of Medical Sciences University: lead

MeSH Terms

Interventions

Fentanyl; Clonidine

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Imidazolines; Imidazoles; Azoles

Study Officials

• Dr.Mrs. Bhavini B Shah, MBBS DA

  Pravara Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Dr.Mrs.Smita S Joshi, MD DA

  Pravara Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 15, 2010
• First Posted: September 20, 2010
• Study Start: August 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: November 1, 2011
• Last Updated: September 21, 2017

Record last verified: 2010-09