Phase 3 N=50 Randomized Double-blind Treatment

A Comparative Study of Intrathecal Magnesium Sulphate & Midazolam With Epidural Ropivacaine for Caesarean Patients

Postoperative Pain

Bottom Line

View on ClinicalTrials.gov: NCT02619799 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2016

Primary outcome: Primary: Duration of Postoperative Analgesia — 334; 280 time in minutes

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: intrathecal magnesium sulphate, (Drug); Intrathecal midazolam (Drug)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: Rangaraya Medical College
Primary completion: Dec 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Duration of Postoperative Analgesia	334; 280	—
SECONDARY Onset of Sensory Blockade	9.86; 7.93	—
SECONDARY Duration of Sensory Blockade	295; 245	—
SECONDARY Onset of Motor Blockade	12.5; 7.68	—
SECONDARY Duration of Motor Blockade	265; 223	—
SECONDARY Perioperative Side Effects	2; 3; 1; 3	—

Summary

This study compares whether addition of Magnesium or Midazolam intrathecally to epidurally administered isobaric Ropivacaine improves the quality of blockade, haemodynamics and duration of analgesia post-operatively. 25 parturients were given intrathecal Magnesium and rest of the 25 parturients were given intrathecal Midazolam combined with 0.75% Ropivacaine via epidural route.

Eligibility Criteria

Inclusion Criteria

50 pregnant women
ASA-I and II parturients
Weight 50-80 kgs
Pre-eclampsia

Exclusion Criteria

Thrombocytopenia
HELLP syndrome
Parturients on magnesium therapy
Foetal distress
Parturients on benzodiazepine therapy
Patient refusal
Contraindications to regional anaesthesia

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02619799). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.