Evaluation of the Analgesic Effect of Midazolam and Ketamine as an Additive to Intrathecal Bupivacaine in Patients Undergoing Cesarean Section

Ketamine

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.

Intervention / Treatment

  • placebo(distilled water (DRUG)
    The placebo group (group P) received bupivacaine 10mg combined with 0.5ml distilled water intrathecally .
  • Ketamine (DRUG)
    The ketamine group (groupK) received bupivacaine 10mg combined with 0.1 mg/kg ketamine preservative free intrathecally
  • Midazolam (DRUG)
    The midazolam group (group M) received bupivacaine 10mg combined with0.02 mg/ kg midazolam intrathecally

Condition or Disease

  • Post Operative Pain

Phase

  • Phase 1
  • Phase 2

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 18 Years to 45 Years
    Enrollment: 90 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Prevention

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: May 01, 2011
    Primary Completion: Nov 01, 2011 ACTUAL
    Completion Date: Dec 01, 2011 ACTUAL
    Study First Posted: Jul 28, 2011 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: May 16, 2012

    Sponsors / Collaborators

    Lead Sponsor: Qazvin University Of Medical Sciences
    Responsible Party: N/A

    Location

    Iran
    Qazvin, 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 .

    Participant Groups

    • 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

    • The placebo group (group P) received bupivacaine 10mg combined with 0.5ml distilled water intrathecally .

    Eligibility Criteria

    Sex: Female
    Minimum Age: 18
    Maximum Age: 45
    Age Groups: Adult
    Healthy Volunteers: Yes

    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

    • analgesic administration was initiated by patient request(verbal rating scale\[ VRS\]\>4)

    • 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)

    Secondary Outcomes

    • 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

    • 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

    • The onset of motor block was defined as the time between the end of injection of the intrathecal anesthetic to Bromage block 1

    • hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring 5min before the intrathecal injection
    • hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring 2minutes after intrathecal injection
    • hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring 4minutes after intrathecal injection
    • hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring 6minutes after intrathecal injection
    • hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring 8minutes after intrathecal injection
    • hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring 10 minutes after intrathecal injection
    • hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring 15minutes after intrathecal injection
    • hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring 20 minutes after intrathecal injection
    • hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring 25 minutes after intrathecal injection
    • hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring 30 minutes after intrathecal injection

    • duration of motor block was defined the time from intrathecal injection to Bromage score0

    More Details

    NCT Number: NCT01404442
    Other IDs: ACTRN12611000729921
    Study URL: https://clinicaltrials.gov/study/NCT01404442
    Last updated: Sep 29, 2023