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CTRI Number  CTRI/2024/07/070381 [Registered on: 10/07/2024] Trial Registered Prospectively
Last Modified On: 04/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect of sitting for 1 minute versus lying down immediately after giving spinal anaesthesia on vital parameters like heart rate , blood pressure and oxygen saturation  
Scientific Title of Study   Effect of delay in positioning the patients after subarachnoid block on hemodynamic response 
Trial Acronym  NIL  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Swathi Kamath  
Designation  Junior Resident 
Affiliation  K S Hegde Medical Academy, Deralakatte, Mangalore  
Address  Department of Anaesthesiology K S Hegde Medical Academy,Deralakatte,Mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9482070289  
Fax    
Email  swathi.kamath310@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Murali Shankar Bhat  
Designation  Associate Professor 
Affiliation  K S Hegde Medical Academy, Deralakatte, Mangalore  
Address  Department of Anaesthesiology K S Hegde Medical Academy,Deralakatte,Mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone  8884537753  
Fax    
Email  muralishankarbhat@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Swathi Kamath  
Designation  Junior Resident 
Affiliation  K S Hegde Medical Academy, Deralakatte, Mangalore  
Address  Department of Anaesthesiology K S Hegde Medical Academy,Deralakatte,Mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9482070289  
Fax    
Email  swathi.kamath310@gmail.com  
 
Source of Monetary or Material Support  
Department of Anesthesiology, K S Hegde Medical Academy, Deralakatte, Mangalore , Karnataka 575018 India 
 
Primary Sponsor  
Name  Dr Swathi Kamath 
Address  Department of Anaesthesiology, K S Hegde Medical Academy, Deralakatte, Mangalore 
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 
Dr Swathi Kamath  K. S. Hegde Medical Academy  Department of Anesthesiology, Deralakatte, Mangalore 575018, Karnataka, India
Dakshina Kannada
KARNATAKA 
9482070289

swathi.kamath310@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
K S Hegde Medical Academy Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Immediate supine positioning after subarachnoid block  Patient positioned supine immediately after administering subarachnoid block through midline approach at L3-L4 interspinous space with 25 gauge Quincke-Babcock spinal needle using 3 ml of 0.75% heavy Ropivacaine at the rate of 0.2ml per second  
Intervention  Positioning supine 1 minute after subarachnoid block   Patient is made to sit for 1 minute before positioning supine after administering subarachnoid block through midline approach at L3-L4 interspinous space with 25 gauge Quincke-Babcock spinal needle using 3 ml of 0.75% heavy Ropivacaine at 2ml per second  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA PS 1 and 2
Height 150-180 cm
Patients undergoing lower limb surgeries under subarachnoid block  
 
ExclusionCriteria 
Details  1.Patient’s refusal
2.Patient who cannot comprehend, uncooperative patient
3.Pregnant women
4.Patient’s with any neurological deficits  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
To compare the hemodynamic changes in patients who remain in sitting position for 1 minute with the patients who are placed in supine position immediately after intrathecal injection of hyperbaric 0.75% Ropivacaine  12 hours  
 
Secondary Outcome  
Outcome  TimePoints 
To compare -
Onset of sensory and motor block
Level of sensory and motor block
Duration of block 
12 hours 
 
Target Sample Size   Total Sample Size="74"
Sample Size from India="74" 
Final Enrollment numbers achieved (Total)= "74"
Final Enrollment numbers achieved (India)="74" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   15/07/2024 
Date of Study Completion (India) 30/11/2024 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   After approval from the Institutional Ethics Committee, patients satisfying the inclusion criteria will be enrolled in the study. A thorough pre-anaesthetic evaluation will be done as per institutional protocol. Written informed consent will be taken after explaining the patients in detail regarding the study. All patients will be kept nil per oral and premedicated as per the institutional protocol. Patients will be shifted to the operation theatre. Standard monitors will be attached including electrocardiography, peripheral oxygen saturation and non-invasive blood pressure monitor. All the basal parameters will be recorded. All patients will be co-loaded with Ringer’s lactate solution 10 ml/kg body weight. Patients will be put in sitting position.
Those patients who received subarachnoid block under strict aseptic precautions through midline approach at L3-L4 interspinous space with 25 gauge Quincke-Babcock spinal needle using 3 ml of 0.75% heavy Ropivacaine administered at the rate of 0.2 ml/sec will be taken up for the study. The time of intrathecal drug injection will be noted as time “0” The patients who are made to lie down immediately after giving spinal anaesthesia will be considered as group A. The patients who are made to sit for 1 minute before positioning them supine after giving spinal anaesthesia will be considered as group B. The decision to position the patient after injection of the spinal drug will be of the consultant anaesthesiologist in charge. Sedation will be given as per the institutional protocol.
Following parameters will be assessed:
1. Onset of anaesthesia will be considered when loss of sensation is achieved at L1 dermatome level. Sensory block will be assessed by cold spirit swab method along midclavicular line bilaterally every 2 minutes until 10 minutes, there after every 5 minutes until 30 minutes. The highest dermatome showing sensory analgesia will be taken as the upper segmental level of the block when it remained the same even after 5 minutes. Sensory blockade at the time of shifting from operation theatre will be noted. Duration of sensory block will be considered as from the onset of the block till the patient complains of pain.
2. The motor block of both lower limbs will be assessed using the Modified Bromage Scale every 2 minutes before the onset of the surgery. Onset of motor blockade will be considered when the patient is not able to move feet or knees (modified Bromage grade 3 score). The duration of motor block will be taken as the time from full intensity motor blockade until a Modified Bromage grade 0 score is achieved. 
3. Hemodynamic changes - The changes in heart rate, systolic and diastolic blood pressure and blood oxygen saturation will be recorded
a) every 2 min for first 20 min
b) there after every 5 min for 60 min
c) at 30 min intervals up to 300 min after subarachnoid block
● Hypotension will be defined as a decrease to MAP< 65 mmHg, treated with IV bolus of 6 mg Inj. Ephedrine and 100 ml of Ringer lactate.
● Bradycardia will be defined as HR < 40 beats/min and treated with Inj. Atropine 0.6 mg IV bolus.
● Desaturation is defined as SpO2< 92% and treated with 6 L oxygen per minute.
4. Duration of anaesthesia will be assessed from the time of onset of the anaesthesia till the patient complains of pain postoperatively.
5. Any complications during the procedure will be noted.
(1) Inadequate spinal anaesthesia requiring either repeating the intrathecal drug, or converting to general anaesthesia
(2) Inadequate duration of anaesthesia requiring supplementation of analgesia
(3) Bradycardia and hypotension due to other reasons like blood loss.
(4) Nausea and vomiting
6. Number of times vasopressors, Inj. Ephedrine 6mg IV bolus and Inj. Atropine 0.6mg IV bolus given will be noted.




 
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