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CTRI Number  CTRI/2023/10/059277 [Registered on: 30/10/2023] Trial Registered Prospectively
Last Modified On: 09/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare the pain relieving effect of ketamine versus magnesium sulphate as add-on to bupivacaine given in spinal anaesthesia for caesarean section 
Scientific Title of Study   Comparison of analgesic efficacy of ketamine versus magnesium sulphate as adjuvant to intrathecal bupivacaine in parturients undergoing elective caesarean section – a randomised interventional study at SMS Medical College & attached group of hospital, Jaipur 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Harpreet Kaur 
Designation  Senior Professor 
Affiliation  Sawai Man Singh Medical College 
Address  Department of Anesthesia, second floor, Dhanvantri complex, SMS Hospital, Jaipur, Rajasthan

Jaipur
RAJASTHAN
302004
India 
Phone  9899785993  
Fax    
Email  rupihar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Harpreet Kaur 
Designation  Senior Professor 
Affiliation  Sawai Man Singh Medical College 
Address  Department of Anesthesia, second floor, Dhanvantri complex, SMS Hospital, Jaipur, Rajasthan


RAJASTHAN
302004
India 
Phone  9899785993  
Fax    
Email  rupihar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Navdeep Kumar Mansinghka 
Designation  Junior Resident 
Affiliation  Sawai Man Singh Medical College 
Address  Department of Anesthesia, second floor, Dhanvantri complex, SMS Hospital, Jaipur, Rajasthan

Jaipur
RAJASTHAN
302004
India 
Phone  9783392062  
Fax    
Email  nmansinghka5@gmail.com  
 
Source of Monetary or Material Support  
Department of anaesthesiology, SMS medical college, Jaipur 
 
Primary Sponsor  
Name  Sawai Man Singh Medical College and Hospital 
Address  Department of Anesthesia, second floor, Dhanvantri complex, SMS Hospital, Jaipur, Rajasthan  
Type of Sponsor  Government medical college 
 
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 
Navdeep Kumar Mansinghka  Sawai Man Singh Medical College and Hospital  Department of Anesthesia, second floor, Dhanvantri complex, SMS Hospital, Jaipur, Rajasthan
Jaipur
RAJASTHAN 		 9783392062

nmansinghka5@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Office of ethics committee, SMS Medical college snd attached hospitals, Jaipur   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  pregnant women going for lower segment caesarean section  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Adding ketamine as an adjuvant to intrathecal bupivacaine at the time of spinal anaesthesia at 0 minutes  Spinal anaesthesia with 0.5% hyperbaric bupivacaine 1.8 ml (9 mg) with preservative free 25mg (0.5ml ) of preservative free ketamine will be given and parameters such as Time of onset of sensory loss,Time of onset of motor loss,Time taken for sensory regression,Time taken for motor regression,Duration of analgesia will be recorded  
Comparator Agent  Adding magnesium sulphate as an adjuvant to intrathecal bupivacaine at the time of spinal anaesthesia at 0 minutes  Spinal anaesthesia with 0.5% hyperbaric bupivacaine 1.8 ml (9 mg) with inj. Magnesium sulphate (75 mg) 0.15ml plus 0.35ml of 0.9% normal saline will be given and parameters such as Time of onset of sensory loss,Time of onset of motor loss,Time taken for sensory regression,Time taken for motor regression,Duration of analgesia will be recorded 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  patients going for elective caesarean section under spinal anaesthesia.Patients who will give informed written consent in vernacular language.Belonging to ASA Classes II status.Height of the parturient 145–170 cm. 
 
ExclusionCriteria 
Details  Patients with systemic diseases.Patients with body mass index >38kg/cm2.Patients having history of preeclampsia and eclampsia,fetal distress. Patients having allergy to study drug.Patients having contraindications to spinal anaesthesia.
• Patients consuming tranquilizers, hypnotics, sedatives. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. To assess & compare between two groups the mean duration of analgesia.
2. To determine difference in mean time duration of sensory onset of spinal anaesthesia
between bupivacaine & ketamine versus bupivacaine and magnesium sulphate in
parturients undergoing elective caesarean section using pin prick method.
3. To assess and compare between two groups the mean time duration in motor onset
using bromage score.
4. To assess and compare between two groups the mean time duration for sensory
regression using pin prick sensation.
5. To assess and compare between two groups the mean time duration for motor regression
using bromage scale. 		 Blood pressure, pluse rate, ECG, & pulse oximetry will be recorded every 5 minute intervals during the first 15 minutes of surgery & then every 15 minutes until the end of the surgery. Sensory block level will be assessed based on loss of sensation to pinprick immediately after the subject is made supine & every 1 minute thereafter until block reached T6 sensory level. The measured time will be recorded as the onset of complete sensory block, & at this time, surgery will be allowed. 
 
Secondary Outcome  
Outcome  TimePoints 
1. To assess & compare hemodynamic changes between the two groups.
2. Study any adverse effects associated with drugs given. 		 0 minutes
5 minutes
10 minutes
15 minutes
30 minutes
45 minutes 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   02/11/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  02/11/2023 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
In this study, we plan to study and draw a comparison of additives like ketamine and magnesium sulphate to hyperbaric bupivacaine to determine their effectiveness in improving the overall quality of anaesthesia in parturients posted for elective caesarean sections.
For this a total of Sixty patients (n=60) undergoing elective caesarean section who satisfy the inclusion criteria will be randomly divided into two groups of 30 each(A and B). Group A patients will be receiving intrathecal ketamine (25 mg) as additive to hyperbaric bupivacaine and group B will be receiving magnesium sulphate (75 mg) as additive to hyperbaric bupivacaine.
When patients arrive in the operating room (OR), intravenous cannula (IV cannula) will be inserted and hemodynamic variables will be measured. After this spinal anaesthesia will be administered using ketamine as an additive to bupivacaine in group A and magnesium sulphate in group B. Surgery will be allowed to proceed after the block reaches T6 sensory level (complete sensory block). Quantitative values of time of onset of sensory loss, time of onset of motor loss, time taken for sensory regression, time taken for motor regression, duration of analgesia will be recorded.
 
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