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

Postoperative Pain Clinical Trial

Official title:

A Comparative Study Between Intrathecal Magnesium Sulphate Versus Midazolam Along With Epidural 0.75% Ropivacaine in Combined Spinal Epidural Technique for Preeclampsia Parturients Undergiong Elective Caesarean Section

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02619799
• Other study ID #: Rangaraya medical college
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 19, 2015
• Last updated: February 12, 2016
• Start date: January 2015
• Est. completion date: December 2015

Study information

• Verified date: November 2015
• Source: Rangaraya Medical College
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

Magnesium sulphate and Midazolam have been used in clinical trials as adjuvants to local anaesthetics via intrathecal and epidural routes and are effective in augmenting the quality of block and prolonging post-operative analgesia.

Noxious stimulation leads to the release of glutamate and aspartate neuratransmitters which bind to various sub-classes of excitatory aminoacid, including the NMDA receptor. Intrathecal magnesium potentiates neuraxial anaesthesia by blocking NMDA receptors with out causing significant side effects as reported in various studies.

Intrathecal Midazolam produces antinociception at spinal cord-level through benzodiazepine GABA-A receptor complex which are present abundantly in the lamina 2 of spinal cord. Midazolam also releases endogenous opioid acting at spinal delta receptors and also enhances adenosine release which also augments analgesia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 28 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• intrathecal magnesium sulphate,
comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine
• Intrathecal midazolam
comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rangaraya Medical College

References & Publications (1)

Culebras X, Gaggero G, Zatloukal J, Kern C, Marti RA. Advantages of intrathecal nalbuphine, compared with intrathecal morphine, after cesarean delivery: an evaluation of postoperative analgesia and adverse effects. Anesth Analg. 2000 Sep;91(3):601-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of Postoperative Analgesia	pain is assessed using visual analogue scale every hour after completion of surgery until first 12 postoperative hours.	first 12 hours after completion of surgery.	Yes
Secondary	Onset of Sensory Blockade	the onset time of sensory blockade was assessed with pinprick .	every 2- 3 minutes for initial 20 minutes ,then every 30 min intervals for first 6 -8 hrs after completion of surgery..	Yes
Secondary	Duration of Sensory Blockade	the duration of sensory blockade was assessed with pinprick .	every 2- 3 minutes for initial 20 minutes ,then every 30 min intervals for first 6 -8 hrs after completion of surgery..	Yes
Secondary	Onset of Motor Blockade	assessed with modified bromage scale.	every 5 minute intervals for initial 30 min , then every 30 minute intervals for first 6-8 hrs after completion of surgery.	Yes
Secondary	Duration of Motor Blockade	assessed with modified bromage scale.	every 5 minute intervals for initial 30 min , then every 30 minute intervals for first 6-8 hrs after completion of surgery.	Yes
Secondary	Perioperative Side Effects	through out the intraoperative period and initial 12 hours postoperatively parturients were assessed for PONV,sedation,respiratory depression hypotension ,bradycardia and shivering.	through out the intraoperative period and first 12 postoperative hours.	Yes