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

NCT01404442 | Completed Phase 1 DMC

• 1 other identifier: ACTRN12611000729921
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain

Keywords

midazolam; ketamine; intrathecal; pain

Outcome Measures

Primary Outcomes (2)

• Time to first requirement of analgesic supplement

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

  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.)

• Postoperative analgesic requirements

  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)

  24 hours postoperative(Time from the injection of intrathecal anesthetic solution to 24 hours postoperative)

Secondary Outcomes (14)

• Sensory block onset time will be assessed by a pinprick test

  sensory block will be assessed by pinprick test every 10 seconds following intrathecal injection

• duration of sensory block will be assessed by a pinprick test

  sensory block 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

  every10 seconds following intrathecal injection

• 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

Study Arms (3)

Ketamine

ACTIVE COMPARATOR

The ketamine group (groupK) received bupivacaine 10mg combined with 0.1 mg/kg ketamine preservative free intrathecally .

Drug: Ketamine

midazolam

ACTIVE COMPARATOR

The midazolam group (group M) received bupivacaine 10mg combined with0.02 mg/ kg midazolam intrathecally

Drug: Midazolam

placebo

PLACEBO COMPARATOR

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

Drug: placebo(distilled water

Interventions

placebo(distilled water DRUG

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

placebo

Ketamine DRUG

The ketamine group (groupK) received bupivacaine 10mg combined with 0.1 mg/kg ketamine preservative free intrathecally

Ketamine

Midazolam DRUG

The midazolam group (group M) received bupivacaine 10mg combined with0.02 mg/ kg midazolam intrathecally

midazolam

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qazvin University Of Medical Sciences: lead

Study Sites (1)

Qazvin university of medical science

Qazvin, Qazvin Province, Iran

Location

Related Publications (1)

• 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.

  PMID: 24529671 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

Ketamine; Midazolam

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Marzieh Beigom Khezri

  Qazvin medical science university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: July 21, 2011
• First Posted: July 28, 2011
• Study Start: May 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: December 1, 2011
• Last Updated: May 17, 2012

Record last verified: 2012-05

Locations

IR (1)