FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2018/01/011509 [Registered on: 23/01/2018] Trial Registered Retrospectively
Last Modified On: 18/01/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of magnesium sulphate on prolonging the duration of analgesia in inguinal hernia surgeries 
Scientific Title of Study   Effect of intravenous magnesium sulphate on block characteristics and post operative analgesia for inguinal hernia surgeries under spinal anaesthesia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jerry Jame Joy 
Designation  JUNIOR RESIDENT 
Affiliation  Government Medical college 
Address  Department of Anaesthesiology Vijayanagar Institute of Medical Sciences. Ballari

Bellary
KARNATAKA
583104
India 
Phone  9846147163  
Fax    
Email  jerryjamejoy@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Srinivasalu D 
Designation  Professor and HOD 
Affiliation  Government Medical college 
Address  Department of Anaesthesiology. Vijayanagar Institute of Medical Sciences. Ballari

Bellary
KARNATAKA
583104
India 
Phone  9846147163  
Fax    
Email  drsrinivasd@gmail.com  
 
Details of Contact Person
Public Query  
Name  Jerry Jame Joy 
Designation  Junior Resident 
Affiliation  Government Medical college 
Address  Department of Anaesthesiology Vijayanagr Institute of Medical Sciences. BALLARI

Bellary
KARNATAKA
583104
India 
Phone  9846147163  
Fax    
Email  jerryjamejoy@gmail.com  
 
Source of Monetary or Material Support  
Vijayanagar institute of Medical Sciences. 
 
Primary Sponsor  
Name  JERRY JAME JOY 
Address  DEPARTMENT OF ANAESTHESIOLOGY VIJAYANAGAR INSTITUTE OF MEDICAL SCIENCES, BALLARI 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
JERRY JAME JOY  Vijayanagar institute of Medical Sciences  Department of Anaesthesiology.
Bellary
KARNATAKA 		 9846147163

jerryjamejoy@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICAL COMMITTEE, VIJAYANAGAR INSTITUTE OF MEDICAL SCIENCES   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  INGUINAL HERNIA,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  INTRAVENOUS MAGNESIUM SULPHATE   Intravenous magnesium Sulphate is administered as bolus dose of 30 mg/kg over 15 minutes followed by an infusion of 15 mg/kg for one hour along with the spinal anaesthesia with 10mg of 0.5% Bupivacaine heavy(2ml) and 25 microgram fentanyl (o.5ml) 
Comparator Agent  Normal saline  intravenous 50 ml of normal saline over 15 min was administered as a bolus dose followed by infusion at the rate of 100 ml/h for 1 hour along with the spinal anaesthesia with 10mg of 0.5% Bupivacaine heavy(2ml) and 25 microgram fentanyl (o.5ml) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  ASA I & II 
 
ExclusionCriteria 
Details  Patient refusal for the procedure
ASA III & IV.
Age <18 & >55 years.
Contraindication to spinal anaesthesia.
History of allergy to test drugs.
Patients with altered Magnesium levels.
Prior intake/supplementation of Magnesium for any reason
Preoperative analgesic administration 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Duration of Analgesia  1.Time from intrathecal administration of drug to the time when patient complaints of pain at the surgical site or VAS score reaches greater than four 
 
Secondary Outcome  
Outcome  TimePoints 
1.onset of sensory blockade
2.Onset of motor blockade
3. Duration of sensory blockade
4. Duration of motor blockade 		 1.Onset of sensory blockade: Time interval from subarachnoid injection to loss of pinprick sensation at T10 level.
2.Onset of motor blockade: time to attain modified Bromage scale 3
3.Duration of sensory blockade:time interval from highest sensory level to complete recovery of sensory blockade.
4.Duration of motor blockade: time to regain Modified Bromage Grade 1. 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/11/2015 
Date of Study Completion (India) 05/01/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  
A prospective, randomized double blind clinical study was undertaken to evaluate the effects of intravenous magnesium sulphate on block characteristics and post operative analgesia for inguinal hernia surgeries under spinal anaesthesia.
Eighty patients were divided into two groups based on computer generated randomization code, each group consisting of forty patients. All the patients were given spinal anaesthesia with 10 mg of 0.5% hyperbaric bupivacaine (2ml) plus 25μg of fentanyl (0.5 ml).
Patients in Group A were administered a bolus dose of magnesium sulphate 30 mg/kg over 15 min, immediately after the administration of spinal drug and followed by an intravenous infusion 15 mg/kg/hr for 1 hour.
Patients in group B were administered a bolus of 50 ml of normal saline over 15 min, immediately after the administration of spinal drug followed by intravenous infusion of normal saline at the rate of 100 ml/hr for 1 hour.
All patients aged between 18 -55 years ,belonging to ASA class I and II posted for inguinal hernia surgery under spinal anesthesia were included in the study. Patients who had contraindication for spinal anaesthesia, history of allergy to test drugs, altered magnesium levels and significant cardiac, renal, respiratory, metabolic disorders were excluded from the study.
The parameters observed were
ï‚· Onset of sensory blockade
ï‚· Maximum level of sensory blockade.
ï‚· Onset of motor blockade.
ï‚· Duration of motor blockade.
ï‚· Duration of sensory blockade
ï‚· Duration of analgesia
ï‚· Haemodynamic parameters
It was found that there was no significant difference between the magnesium group and control group with regards to the onset of sensory and motor blockade, the maximum level of sensory blockade and the time taken to attain the maximum sensory level.
The duration of the sensory blockade was 192.45 ± 12.89 minutes in the magnesium group, and 167.37 ± 13.25 minutes in the control group. The difference of 25 minutes was statistically highly significant. The duration of analgesia was significantly prolonged being 267.37 ± 29.35 minutes in the magnesium group and 156.25 ± 14 minutes in the control group. The mean duration of the motor blockade was 161.72 ± 10.85 minutes in the magnesium group and 140.5 ± 11.36 minutes in the control group, which was highly statistically significant.
The serum magnesium levels were significantly higher in the magnesium group 24 hours after the surgery, being 0.86 ± 0.086 mmol/l and 0.82 ±0.076 mmol/l in the control group. But it may not be clinically significant as all the values were within the normal range.
The incidence of hypotension was comparatively more in the magnesium group but it was not statistically significant. Other adverse effects like respiratory depression, arrhythmias were not observed.
 
Close