Phase 3
Completed N=50
A Comparative Study of Intrathecal Magnesium Sulphate & Midazolam With Epidural Ropivacaine for Caesarean Patients
Source: ClinicalTrials.gov NCT02619799 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcomePrimary: Duration of Postoperative Analgesia — 334; 280 time in minutes
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.
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 | — |
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
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. Informational only — not medical advice.