Clinical trial NCT01404442: Evaluation of the Analgesic Effect of Midazolam and Ketamine as an Additive to Intrathecal Bupivacaine in Patients Undergoing Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Post Operative Pain
Keywords: midazolam
ketamine
intrathecal
pain
Lead sponsor: Qazvin University Of Medical Sciences
Sponsor class: OTHER
First posted: 2011-07-28
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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 .

Eligibility criteria: Inclusion Criteria:

* patients with American Society of Anesthesiologists(ASA) physical status I and II, undergoing elective cesarean section

Exclusion Criteria:

* significant coexisting disease such as hepato-renal and cardiovascular disease
* 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.

Primary outcomes:
measure: Time to first requirement of analgesic supplement
timeFrame: 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.)
measure: Postoperative analgesic requirements
timeFrame: 24 hours postoperative(Time from the injection of intrathecal anesthetic solution to 24 hours postoperative)
Secondary outcomes:
measure: Sensory block onset time will be assessed by a pinprick test
timeFrame: sensory block will be assessed by pinprick test every 10 seconds following intrathecal injection
measure: duration of sensory block will be assessed by a pinprick test
timeFrame: sensory block will be assessed by pinprick test every 5 minuts following intrathecal injection
measure: the onset of motor block will be assessed by the modified Bromage score
timeFrame: every10 seconds following intrathecal injection
measure: hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
timeFrame: 5min before the intrathecal injection
measure: hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
timeFrame: 2minutes after intrathecal injection
measure: hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
timeFrame: 4minutes after intrathecal injection
measure: hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
timeFrame: 6minutes after intrathecal injection
measure: hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
timeFrame: 8minutes after intrathecal injection
measure: hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
timeFrame: 10 minutes after intrathecal injection
measure: hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
timeFrame: 15minutes after intrathecal injection
measure: hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
timeFrame: 20 minutes after intrathecal injection
measure: hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
timeFrame: 25 minutes after intrathecal injection
measure: hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring
timeFrame: 30 minutes after intrathecal injection
measure: duration of motor block will be assessed by the modified Bromage score
timeFrame: every 5 minutes following intrathecal injection
Other outcomes:
Locations:
city: Qazvin
country: Iran, Islamic Republic of
facility: Qazvin university of medical science
Study officials:
affiliation: Qazvin medical science university
name: Marzieh Beigom Khezri
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.