Main
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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:
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CTRI |
Last refreshed on:
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24 November 2021 |
Main ID: |
CTRI/2015/07/005963 |
Date of registration:
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05-07-2015 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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To study different doses of magnesium sulphate with bupivacaine under spinal anesthesia in surgeries below umbilicus
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Scientific title:
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To study different doses of magnesium sulphate as an adjunct to bupivacaine in infraumbilical surgeries under spinal anesthesia |
Date of first enrolment:
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12-02-2013 |
Target sample size:
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90 |
Recruitment status: |
Completed |
URL:
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=9666 |
Study type:
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Interventional |
Study design:
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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
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Phase:
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Phase 2
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Countries of recruitment
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India
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Contacts
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Name:
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Dr Sudarshan kumar
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Address:
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Department of anesthesia
Dr R.P.G.M.C
Tanda
176004
Kangra, HIMACHAL PRADESH
India |
Telephone:
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9418086604 |
Email:
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sudarshan_58@rediffmail.com |
Affiliation:
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DR.R.P.G.M.C TANDA |
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Name:
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Dr Sudarshan kumar
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Address:
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Dept of anesthesia
Dr R.P.G.M.C
Tanda
176004
Kangra, HIMACHAL PRADESH
India |
Telephone:
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9418086604 |
Email:
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sudarshan_58@rediffmail.com |
Affiliation:
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DR.R.P.G.M.C TANDA |
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Key inclusion & exclusion criteria
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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:
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Health Condition(s) or Problem(s) studied
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Intervention(s)
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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
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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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.
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Source(s) of Monetary Support
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Department of anesthesiology
Dr R.P.G.M.C Kangra at Tanda
Himachal Pradesh
India
176004
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Ethics review
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Status: Approved
Approval date: 22/12/2012
Contact:
Institutional Ethics Committee of Dr.R.P.G.M.C Kangra at Tanda
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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