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

Phase 1

Completed

• Conditions: Post Operative Pain
• Interventions: Drug: Midazolam; Drug: Ketamine; Drug: placebo(distilled water

• Registration Number: NCT01404442
• Lead Sponsor: Qazvin University Of Medical Sciences

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 Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-07-21
• Study First Submitted QC: 2011-07-27
• Study First Posted: 2011-07-28
• Primary Completion: 2011-11
• Study Completion: 2011-12
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-16
• Last Update Posted: 2012-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Time to first requirement of analgesic supplement	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	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)

Secondary Outcome Measures

Name	Time	Method
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	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	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	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	30 minutes after intrathecal injection
duration of motor block will be assessed by the modified Bromage score	every 5 minutes following intrathecal injection	duration of motor block was defined the time from intrathecal injection to Bromage score0

Trial Locations

Locations (1)

Qazvin university of medical science; 🇮🇷 Qazvin, Iran, Islamic Republic of