Evaluation of the Analgesic Effect of Midazolam and Ketamine as an Additive to Intrathecal Bupivacaine in Patients Undergoing Cesarean Section
NCT ID: NCT01404442
Last Updated: 2012-05-17
Study Results
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Basic Information
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COMPLETED
PHASE1/PHASE2
90 participants
INTERVENTIONAL
2011-05-31
2011-12-31
Brief Summary
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Methods:Following Ethics Committee approval and informed patients consent, Ninety patients 18-45 yr old ASA physical status I or II, scheduled for cesarean section under spinal anesthesia, were studied in a prospective, double-blinded, randomized way. The patients were randomly allocated to one of three groups of 30 each. The ketamine group (groupK) received bupivacaine 10mg combined with 0.1 mg/kg ketamine preservative free ,the midazolam group (group M) received bupivacaine 10mg combined with0.02 mg/ kg midazolam and the placebo group (group P) received bupivacaine 10mg combined with 0.5ml distilled water intrathecally . Time to first requirement of analgesic supplement, Sensory block onset time, maximum sensory level , onset of motor block, duration of blockade, hemodynamics variables, the incidence of hypotension, ephedrine requirements, bradycardia ,hypoxemia \[Saturation of peripheral oxygen (SpO2)\<90\], postoperative analgesic requirements and Adverse events, such as sedation, dizziness , Pruritus and postoperative nausea and vomiting were recorded. Patients were instructed preoperatively in the use of the verbal rating scale (VRS) from 0 to 10 (0no pain, 10maximum imaginable pain) for pain assessment. If the VRS exceeded four and the patient requested a supplement analgesic, diclofenac Na supp 100 mg was to be given for post-operative pain relief as needed . For breakthrough pain(VRS \>4) if time of administration of diclofenac Na less than 8h,Pethidine 25 mg IV was given.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Ketamine
The ketamine group (groupK) received bupivacaine 10mg combined with 0.1 mg/kg ketamine preservative free intrathecally .
Ketamine
The ketamine group (groupK) received bupivacaine 10mg combined with 0.1 mg/kg ketamine preservative free intrathecally
midazolam
The midazolam group (group M) received bupivacaine 10mg combined with0.02 mg/ kg midazolam intrathecally
Midazolam
The midazolam group (group M) received bupivacaine 10mg combined with0.02 mg/ kg midazolam intrathecally
placebo
The placebo group (group P) received bupivacaine 10mg combined with 0.5ml distilled water intrathecally .
placebo(distilled water
The placebo group (group P) received bupivacaine 10mg combined with 0.5ml distilled water intrathecally .
Interventions
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placebo(distilled water
The placebo group (group P) received bupivacaine 10mg combined with 0.5ml distilled water intrathecally .
Ketamine
The ketamine group (groupK) received bupivacaine 10mg combined with 0.1 mg/kg ketamine preservative free intrathecally
Midazolam
The midazolam group (group M) received bupivacaine 10mg combined with0.02 mg/ kg midazolam intrathecally
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* any contraindication to regional anesthesia such as local infection or bleeding disorders
* allergy to ketamine or midazolam
* long-term opioid use or a history of chronic pain.
18 Years
45 Years
FEMALE
No
Sponsors
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Qazvin University Of Medical Sciences
OTHER
Responsible Party
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marzieh beigom khezri
Assistant professor
Principal Investigators
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Marzieh Beigom Khezri
Role: PRINCIPAL_INVESTIGATOR
Qazvin medical science university
Locations
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Qazvin university of medical science
Qazvin, Qazvin Province, Iran
Countries
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References
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Khezri MB, Ghasemi J, Mohammadi N. Evaluation of the analgesic effect of ketamine as an additive to intrathecal bupivacaine in patients undergoing cesarean section. Acta Anaesthesiol Taiwan. 2013 Dec;51(4):155-60. doi: 10.1016/j.aat.2013.12.004. Epub 2014 Jan 21.
Other Identifiers
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ACTRN12611000729921
Identifier Type: -
Identifier Source: org_study_id
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