Qazvin university of medical science
Qazvin, Qazvin Province, Iran
NCT Number: NCT01404442
Objective :To compare the analgesic effect of intrathecal midazolam and ketamine as an additive to bupivacaine in patients undergoing cesarean section .
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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Notify Me18 year–45 year
Female
Interventional
Phase 1 / Phase 2
Qazvin, Qazvin Province, Iran
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 .
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The placebo group (group P) received bupivacaine 10mg combined with 0.5ml distilled water intrathecally .
The ketamine group (groupK) received bupivacaine 10mg combined with 0.1 mg/kg ketamine preservative free intrathecally
The midazolam group (group M) received bupivacaine 10mg combined with0.02 mg/ kg midazolam intrathecally
Time frame: participants will be followed for the duration of 24 hours after intratechal injection (Time from the injection of intrathecal anesthetic solution to first requirement of analgesic supplement will be recorded.)
analgesic administration was initiated by patient request(verbal rating scale[ VRS]>4)
Time frame: 24 hours postoperative(Time from the injection of intrathecal anesthetic solution to 24 hours postoperative)
postoperative analgesic requirements will be assessed by verbal rating scale (VRS) from 0 to 10 (0no pain, 10maximum imaginable pain).Each administration was initiated by patient request( VRS>4)
Time frame: sensory block will be assessed by pinprick test every 10 seconds following intrathecal injection
The onset of sensory block was defined as the time between the end of injection of the intrathecal anesthetic and the absence of pain at the T10 dermatome
Time frame: sensory block will be assessed by pinprick test every 5 minuts following intrathecal injection
The duration of sensory block was defined as the time for regression from the maximum block height sensory block to T10 dermatom will be assessed by pinprick test every 5 minuts following intrathecal injection
Time frame: every10 seconds following intrathecal injection
The onset of motor block was defined as the time between the end of injection of the intrathecal anesthetic to Bromage block 1
Time frame: 5min before the intrathecal injection
Time frame: 2minutes after intrathecal injection
Time frame: 4minutes after intrathecal injection
Time frame: 6minutes after intrathecal injection
Time frame: 8minutes after intrathecal injection
Time frame: 10 minutes after intrathecal injection
Time frame: 15minutes after intrathecal injection
Time frame: 20 minutes after intrathecal injection
Time frame: 25 minutes after intrathecal injection
Time frame: 30 minutes after intrathecal injection
Time frame: every 5 minutes following intrathecal injection
duration of motor block was defined the time from intrathecal injection to Bromage score0
Qazvin University Of Medical Sciences
Other
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