NCT02619799

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for phase_2 postoperative-pain

Timeline
Completed

Started Jan 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2015

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2015

Completed
2 months until next milestone

Results Posted

Study results publicly available

February 8, 2016

Completed
Last Updated

March 14, 2016

Status Verified

November 1, 2015

Enrollment Period

11 months

First QC Date

November 19, 2015

Results QC Date

January 8, 2016

Last Update Submit

February 12, 2016

Conditions

Postoperative Pain

Keywords

magnesium sulphateintrathecal routemidazolam

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (5)

  • Onset of Sensory Blockade

    every 2- 3 minutes for initial 20 minutes ,then every 30 min intervals for first 6 -8 hrs after completion of surgery..

  • Duration of Sensory Blockade

    every 2- 3 minutes for initial 20 minutes ,then every 30 min intervals for first 6 -8 hrs after completion of surgery..

  • Onset of Motor Blockade

    every 5 minute intervals for initial 30 min , then every 30 minute intervals for first 6-8 hrs after completion of surgery.

  • Duration of Motor Blockade

    every 5 minute intervals for initial 30 min , then every 30 minute intervals for first 6-8 hrs after completion of surgery.

  • Perioperative Side Effects

    through out the intraoperative period and first 12 postoperative hours.

Study Arms (2)

GROUP A(MAGNESIUM GROUP)

ACTIVE COMPARATOR

MAGNESIUM GROUP received 50 mg(0.1 ml) of intrathecal magnesium sulphate diluted to 1 ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.

Drug: intrathecal magnesium sulphate,

GROUP B(MIDAZOLAM GROUP)

ACTIVE COMPARATOR

MIDAZOLAM GROUP received 1mg(0.2ml) of intrathecal midazolam diluted to 1ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.

Drug: Intrathecal midazolam

Interventions

intrathecal magnesium sulphate,DRUG

comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine

Also known as: Magneon
GROUP A(MAGNESIUM GROUP)
Intrathecal midazolamDRUG

comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine

Also known as: Mizolam
GROUP B(MIDAZOLAM GROUP)

Eligibility Criteria

Age18 Years - 28 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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. doi: 10.1097/00000539-200009000-00019.

    PMID: 10960384BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Results Point of Contact

Title
Dr.Paleti Sophia
Organization
Rangaraya medical college
dr.sophia29@gmail.com
9948599758 ,08842343023

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

November 19, 2015

First Posted

December 2, 2015

Study Start

January 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

March 14, 2016

Results First Posted

February 8, 2016

Record last verified: 2015-11

Data Sharing

IPD Sharing
Will not share