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CTRI Number  CTRI/2022/08/044629 [Registered on: 04/08/2022] Trial Registered Prospectively
Last Modified On: 03/08/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   TO ASSESS THE EFFECTIVENESS OF KETAMINE AS PREMEDICANT FOR PREVENTING FALL IN BLOOD PRESSURE AFTER SPINAL ANAESTHESIA IN PARTURIENTS POSTED FOR ELECTIVE CAESAREAN SECTION- A PROSPECTIVE RANDOMIZED DOUBLE BLIND CONTROLLED STUDY 
Scientific Title of Study   EFFICACY OF INTRAVENOUS KETAMINE AS PREMEDICANT FOR PREVENTION OF INTRA- OPERATIVE HYPOTENSION AFTER SPINAL ANAESTHESIA IN PARTURIENTS POSTED FOR ELECTIVE CAESAREAN SECTION- A PROSPECTIVE RANDOMIZED DOUBLE BLIND CONTROLLED STUDY 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SAMBREKAR SUDEEPTA MADAN  
Designation  Post graduate  
Affiliation  JSS MEDICAL COLLEGE AND HOSPITAL  
Address  DEPARTMENT OF ANAESTHESIOLOGY, JSS MEDICAL COLLEGE AND HOSPITAL, RAMACHANDRA, AGRAHARA, MYSURU

Mysore
KARNATAKA
570004
India 
Phone  8762559174  
Fax    
Email  sudeeptams2426@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  PROF Dr MANJULA B P 
Designation  PROFESSOR  
Affiliation  JSS MEDICAL COLLEGE AND HOSPITAL  
Address  DEPARTMENT OF ANAESTHESIOLOGY, JSS MEDICAL COLLEGE AND HOSPITAL, RAMACHANDRA, AGRAHARA, MYSURU

Mysore
KARNATAKA
570004
India 
Phone  9845501226  
Fax    
Email  bpmanjula5@gmail.com  
 
Details of Contact Person
Public Query
 
Name  PROF Dr MANJULA B P 
Designation  PROFESSOR  
Affiliation  JSS MEDICAL COLLEGE AND HOSPITAL  
Address  DEPARTMENT OF ANAESTHESIOLOGY, JSS MEDICAL COLLEGE AND HOSPITAL, RAMACHANDRA, AGRAHARA, MYSURU

Mysore
KARNATAKA
570004
India 
Phone  9845501226  
Fax    
Email  bpmanjula5@gmail.com  
 
Source of Monetary or Material Support  
JSS MEDICAL COLLEGE AND HOSPITAL  
 
Primary Sponsor  
Name  JSS MEDICAL COLLEGE AND HOSPITAL  
Address  DEPARTMENT OF ANAESTHESIOLOGY, JSS MEDICAL COLLEGE AND HOSPITAL, RAMACHANDRA, AGRAHARA, MYSURU 570004 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
SAMBREKAR SUDEEPTA MADAN   JSS MEDICAL COLLEGE AND HOSPITAL   OT COMPLEX, DEPARTMENT OF ANAESTHESIOLOGY
Mysore
KARNATAKA 
8762559174

sudeeptams2426@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 1||Obstetrics, (2) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  KETAMINE  15 MG OF KETAMINE BOLUS DOSE WILL BE GIVEN INTRAVENOUSLY TO ONE GROUP JUST BEFORE INJECTING SPINAL DRUG. 
Comparator Agent  NORMAL SALINE  15 ML OF NORMAL SALINE WILL BE GIVEN INTRAVENOUSLY TO OTHER GROUP JUST BEFORE INJECTING SPINAL DRUG. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  PARTURIENTS OF ASA PHYSICAL CLASS II UNDERGOING ELECTIVE LOWER SEGMENT CAESAREAN SECTION UNDER SPINAL ANAESTHESIA. 
 
ExclusionCriteria 
Details  1. CONTRAINDICATIONS TO REGIONAL ANAESTHESIA
2. PARTURIENTS WITH PLACENTA PREVIA, PREECLAMPSIA, CARDIOVASCULAR OR CEREBROVASCULAR DISEASE, GESTATIONAL DIABETES.
3. GESTATIONAL AGE <36 WEEKS OR > 41 WEEKS.
4. PRE- EXISTING ABNORMAL NEUROLOGICAL OR PSYCHIATRIC DISEASES.
5. HISTORY OF ALLERGY TO KETAMINE.
6. BMI >30 KG/M2.
7. PARTURIENT HEIGHT <150 CM OR > 170 CM. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
TO STUDY THE INCIDENCE OF HYPOTENSION AFTER SPINAL ANAESTHESIA IN CAESAREAN SECTION.  THE FIRST 60 MINUTES FOLLOWING SPINAL ANAESTHESIA WILL BE CONSIDERED FOR ANAESTHESIA INDUCED HYPOTENSION. 
 
Secondary Outcome  
Outcome  TimePoints 
TO STUDY THE POSTOPERATIVE ANALGESIC AND SEDATIVE EFFECT OF KETAMINE, TO STUDY THE FETAL OUTCOME BY ASSESSING THE APGAR SCORE  5 MINUTES UPTILL 24 HOURS 
 
Target Sample Size   Total Sample Size="98"
Sample Size from India="98" 
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   N/A 
Date of First Enrollment (India)   04/08/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="30" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Informed and written consent will be taken from 98 parturients of American Society of Anaesthesiologists Physical status (ASA) class II undergoing elective lower segment caesarean section under spinal anaesthesia. Randomization of parturients will be done by shuffled sealed opaque envelope technique.

A thorough pre- anaesthetic evaluation will be done 24 hours prior to the procedure. Standard monitoring with electrocardiography (ECG), automated non-invasive blood pressure (NIBP) and pulse oximetry (saturation- SpO2) will be done for baseline values and intraoperative monitoring using a multipara meter Philips IntelliVue MP20/MP30 monitor. 

Parturients will be divided into two groups:-

GROUP K:- Those who will receive 15 mg of intravenous Ketamine in 3 ml of normal saline. 

GROUP C:- Those who will receive 3 ml of normal saline.

 

This will be a double-blind study. The study drugs will be prepared by the same anaesthesiologist who does the randomization and administered by the observer. Hence, the observer and parturient will be blinded to the study drugs. The baseline hemodynamic values will be recorded in the supine position (with wedge under the right buttock to prevent aortocaval obstruction). 

 

Intravenous (IV) access will be established in the upper limb. Each parturient will be started on IV infusion of Ringer lactate at 5- 7 ml/kg prior to the subarachnoid block (SAB) in the operating room. The baseline values of SBP (systolic blood pressure), DBP (diastolic blood pressure), MAP (mean arterial pressure), HR (heart rate), ECG and saturation will be recorded. The parturients will then be turned to lateral position. The study drugs will be administered by the observer immediately before the injection of the spinal agent. Spinal anaesthesia will be performed using Quincke’s 25 gauge spinal needle in lateral position with 10 mg of injection bupivacaine 0.5% (hyperbaric) at the L3–L4 interspace with midline approach. The parturient will return to the supine position immediately with a wedge under the right buttock to prevent aortocaval obstruction. Oxygen will be supplemented through face mask at 4L/min. Ringer lactate will be administered at a rate of 100 ml/10 min. The onset and level of sensory block will be checked 5 minutes after the spinal injection and the surgery will be allowed to start after the confirmation of sensory block to T6 level. Maximum level of sensory and motor blockade will be recoded. If a T6 sensory block level is not achieved, these parturients will be excluded from the study and managed according to the institutional protocol. NIBP, HR, respiratory rate (RR) and SpO2 will be recorded at 2 minutes intervals after the SAB up to 20 minutes and then at 5 minutes intervals till the end of surgery. Hypotension defined as a decrease in SBP <20% of baseline or <90mmHg will be recorded and treated with IV bolus of 6mg injection ephedrine. The number of incidences of hypotension, total amount of ephedrine required and number of doses of ephedrine required will be recorded. The first 60 minutes following spinal anaesthesia will be considered for anaesthesia-induced hypotension. Following extraction of the baby, APGAR score will be recorded at 1 and 5 minutes. Injection oxytocin 10 units will be given as uterotonic following baby extraction intramuscularly. Parturients requiring any additional oxytocin and/or additional surgical interventions will be excluded from the study.

 Postoperative monitoring of SBP, DBP, MAP, HR, ECG and SPO2 will be done every hourly for first 6 hours. Post-operative pain will be assessed using the visual analogue scale (VAS). VAS consists of a 10 cm line with 0 equaling “no pain at all” and 10 being the “worst possible pain” 11. The pain will be monitored every 2 hours for first 6 hours and then every 6th hourly for next 18 hours or until first complaint of pain called the “time to first breakthrough pain” which will be considered as the pain requiring treatment (VAS>/= 4 ). Rescue analgesic injection diclofenac 75mg will be given intramuscularly. The number of doses given will be recorded. Ramsay sedation scale will be used to evaluate the sedative effect at baseline, then at 5, 10, 15, 30, 45 minutes after intrathecal injection and then at the end of the operation 1.

Ramsay score

Level of sedation

1

Anxious, agitated, restless

2

Oriented, tranquil

3

Responds to commands

4

Brisk response to light glabellar tap

5

Sluggish response to light glabellar tap

6(deep sedation)

No response

 The incidence of other adverse events such as nausea, vomiting and mood changes if observed any will be recorded. 
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