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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: CTRI
Last refreshed on: 24 November 2021
Main ID:  CTRI/2015/07/005963
Date of registration: 05-07-2015
Prospective Registration: No
Primary sponsor: DR RPGMC Kangra at Tanda
Public title: To study different doses of magnesium sulphate with bupivacaine under spinal anesthesia in surgeries below umbilicus
Scientific title: To study different doses of magnesium sulphate as an adjunct to bupivacaine in infraumbilical surgeries under spinal anesthesia
Date of first enrolment: 12-02-2013
Target sample size: 90
Recruitment status: Completed
URL:  http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=9666
Study type:  Interventional
Study design:  Randomized, Parallel Group, Active Controlled Trial
Method of generating randomization sequence:Random Number Table Method of allocation concealment:Centralized Blinding and masking:Participant and Investigator Blinded
 
Phase:  Phase 2
Countries of recruitment
India
Contacts
Name: Dr Sudarshan kumar   
Address:  Department of anesthesia Dr R.P.G.M.C Tanda 176004 Kangra, HIMACHAL PRADESH India
Telephone: 9418086604
Email: sudarshan_58@rediffmail.com
Affiliation:  DR.R.P.G.M.C TANDA
Name: Dr Sudarshan kumar   
Address:  Dept of anesthesia Dr R.P.G.M.C Tanda 176004 Kangra, HIMACHAL PRADESH India
Telephone: 9418086604
Email: sudarshan_58@rediffmail.com
Affiliation:  DR.R.P.G.M.C TANDA
Key inclusion & exclusion criteria
Inclusion criteria: ASA class 1&2

BMI 18.5-39.9

UNDERGOING INFRAUMBILICAL SURGERIES

Exclusion criteria: Patients refusal for spinal anesthesia

Uncontrolled hypertension

Patients noted to have dysrhythmias on ECG

Allergic to study drugs

Absolute contraindication for spinal anesthesia

BMI >40


Age minimum:
Age maximum:
Gender:
Health Condition(s) or Problem(s) studied
Intervention(s)
Intervention1: Magnesium sulphate in sub arachnoid block: TWO DOSES 50mg & 100mg of magnesium suphate as adjuvant to bupivacaine,total volume being 3cc given intrathecally to two groups of 30 different patients and compared with each other over a period of 18 months.
Intervention2: Magnesium sulphate: TWO DOSES 50mg & 100mg of magnesium suphate given intrathecally as adjuvant to bupivacaine,total volume being 3cc compared with each other,also a control group is compared with them which has only bupivacaine
Control Intervention1: Normal saline: Normal saline added to bupivacine given intrathecally to 30 patients to keep an equal volume of drug(3cc) with MAGNESIUM groups over a period of 18 months
Primary Outcome(s)
a.To study the onset and duration of sensory and motor block.



b.To study the duration of postoperative analgesia and post operative analgesic requirementsTimepoint: a. assesment done every 1 min upto 10 min, then every 5 min upto 30 min,every 10 min upto 60 min,15 min upto 120 min, then 30 min until end of surgery.

b.postoperatively follow up done every hour upto first 6 hrs,then 2 hrly upto 12 hrs,then 3hrly upto 24 hrs.
Secondary Outcome(s)
Hemodynamaic stability (Blood presssure,Heart rate,Respiratory rate,Oxygen saturation)throughout the surgery.Timepoint: Assesment done every 1 min upto first 10 min, then every 5 min upto 30 min,every 10 min upto 60 min,15 min upto 120 min, then 30 min until end of surgery.
Secondary ID(s)
NIL
Source(s) of Monetary Support
Department of anesthesiology Dr R.P.G.M.C Kangra at Tanda Himachal Pradesh India 176004
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 22/12/2012
Contact:
Institutional Ethics Committee of Dr.R.P.G.M.C Kangra at Tanda
Results
Results available:
Date Posted:
Date Completed:
URL:
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