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

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ClinicalTrials.gov Identifier: NCT01404442
Recruitment Status : Completed
First Posted : July 28, 2011
Last Update Posted : May 17, 2012
Sponsor:
Information provided by (Responsible Party):
marzieh beigom khezri, Qazvin University Of Medical Sciences

Tracking Information
First Submitted Date  ICMJE July 21, 2011
First Posted Date  ICMJE July 28, 2011
Last Update Posted Date May 17, 2012
Study Start Date  ICMJE May 2011
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 27, 2011)
  • Time to first requirement of analgesic supplement [ 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)
  • Postoperative analgesic requirements [ 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 27, 2011)
  • Sensory block onset time will be assessed by a pinprick test [ 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
  • duration of sensory block will be assessed by a pinprick test [ 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
  • the onset of motor block will be assessed by the modified Bromage score [ 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
  • hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring [ Time Frame: 5min before the intrathecal injection ]
  • hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring [ Time Frame: 2minutes after intrathecal injection ]
  • hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring [ Time Frame: 4minutes after intrathecal injection ]
  • hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring [ Time Frame: 6minutes after intrathecal injection ]
  • hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring [ Time Frame: 8minutes after intrathecal injection ]
  • hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring [ Time Frame: 10 minutes after intrathecal injection ]
  • hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring [ Time Frame: 15minutes after intrathecal injection ]
  • hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring [ Time Frame: 20 minutes after intrathecal injection ]
  • hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring [ Time Frame: 25 minutes after intrathecal injection ]
  • hemodynamic variables are assessed by noninvasive automatic blood pressure measurement and electrocardiogram monitoring [ Time Frame: 30 minutes after intrathecal injection ]
  • duration of motor block will be assessed by the modified Bromage score [ Time Frame: every 5 minutes following intrathecal injection ]
    duration of motor block was defined the time from intrathecal injection to Bromage score0
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Analgesic Effect of Midazolam and Ketamine as an Additive to Intrathecal Bupivacaine in Patients Undergoing Cesarean Section
Official Title  ICMJE Not Provided
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 .
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Post Operative Pain
Intervention  ICMJE
  • Drug: placebo(distilled water
    The placebo group (group P) received bupivacaine 10mg combined with 0.5ml distilled water intrathecally .
  • Drug: Ketamine
    The ketamine group (groupK) received bupivacaine 10mg combined with 0.1 mg/kg ketamine preservative free intrathecally
  • Drug: Midazolam
    The midazolam group (group M) received bupivacaine 10mg combined with0.02 mg/ kg midazolam intrathecally
Study Arms  ICMJE
  • Active Comparator: Ketamine
    The ketamine group (groupK) received bupivacaine 10mg combined with 0.1 mg/kg ketamine preservative free intrathecally .
    Intervention: Drug: Ketamine
  • Active Comparator: midazolam
    The midazolam group (group M) received bupivacaine 10mg combined with0.02 mg/ kg midazolam intrathecally
    Intervention: Drug: Midazolam
  • Placebo Comparator: placebo
    The placebo group (group P) received bupivacaine 10mg combined with 0.5ml distilled water intrathecally .
    Intervention: Drug: placebo(distilled water
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 27, 2011)
90
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01404442
Other Study ID Numbers  ICMJE ACTRN12611000729921
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party marzieh beigom khezri, Qazvin University Of Medical Sciences
Original Responsible Party Name/Official Title: Marzieh Beigom Khezri, Qazvin University Of Medical Sciences
Current Study Sponsor  ICMJE Qazvin University Of Medical Sciences
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marzieh Beigom Khezri Qazvin medical science university
PRS Account Qazvin University Of Medical Sciences
Verification Date May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP