RecruitingPhase 2ACTRN12611000729921

A comparison of pain relief from three different drug regimes for women undergoing cesarean section

Evaluation of the analgesic effect of Midazolam and ketamine as an Additive to Intrathecal bupivacaine in patients undergoing cesarean section


Sponsor

Qazvin Medical Science University

Enrollment

90 participants

Start Date

May 15, 2011

Study Type

Interventional

Conditions

Summary

Objective :To compare the analgesic effect of intratechal 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.


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 45 Yearss

Plain Language Summary

Simplified for easier understanding

This study is comparing three types of spinal anesthesia for women having a planned cesarean section. All three groups receive the same main anesthetic (bupivacaine) injected into the spine, but each group also gets a different additional medication — either ketamine, midazolam, or a harmless saltwater placebo. Researchers want to find out which combination provides the best pain relief after surgery. You may be eligible if: - You are a woman between 18 and 45 years old - You are having a planned cesarean section under spinal anesthesia - You are in good general health (ASA status I or II) You may NOT be eligible if: - You have significant liver, kidney, or heart disease - You have a condition that prevents spinal anesthesia (such as a bleeding disorder or local infection) - You are allergic to ketamine or midazolam - You use opioids long-term or have chronic pain Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Ninety patients 18-45 yr old American Society of Anesthesiologists ( ASA) physical status I or II, scheduled for cesarean section under spinal anesthesia, were studied in a prospective, double-blinde

Ninety patients 18-45 yr old American Society of Anesthesiologists ( 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 10 mg combined with 0.1mg/kg ketamine preservative free solution ,The midazolam group (groupM) 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) for each three groups 5 minutes prior to surgery)


Locations(1)

Qazvin, Iran, Islamic Republic Of

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ACTRN12611000729921


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