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CTRI Number  CTRI/2024/12/078019 [Registered on: 12/12/2024] Trial Registered Prospectively
Last Modified On: 11/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   The study to compare efficacy and safety of divided doses spinal anaesthesia drug with single dose of spinal anaesthesia drug for elderly patient undergoing vaginal hysterectomy 
Scientific Title of Study   Prospective observational study to compare efficacy and safety of fractionated dose verses single bolus dose in spinal anesthesia for elderly patients undergoing vaginal hysterectomy 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Susheelkumar 
Designation  Junior resident department of anaesthesiology  
Affiliation  Department of anaesthesiology LTMMC SION hospital Mumbai 
Address  Room no 422 ,3rd floor college building department of anaesthesiology LTMMC & GH sion hospital mumbai,India
Room no 405, 4 th floor new rmo hostel LTMMC &GH sion hospital mumbai,India
Mumbai
MAHARASHTRA
400022
India 
Phone  8904744230  
Fax    
Email  susheelkumarkembhavi@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jyoti magar 
Designation  Professor dept of anaesthesiology LTMMC Mumbai  
Affiliation  Department of anaesthesiology LTMMC & GH Sion hospital Mumbai,India  
Address  Room no 422, 3rd floor college building ,Department of anaesthesiology LTMMC &GH ,SION hospital Mumbai ,India

Mumbai
MAHARASHTRA
400022
India 
Phone  9833706466  
Fax    
Email  jyotimagar2110@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jyoti magar 
Designation  Professor department of anaesthesiology LTMMC&GH Sion hospital Mumbai  
Affiliation  Department of anaesthesiology LTMMC &GH SION hospital Mumbai,India 
Address  Room no 422,3rd floor college building ,Department of anaesthesiology LTMMC &GH ,SION hospital Mumbai ,India

Mumbai
MAHARASHTRA
400022
India 
Phone  9833706466  
Fax    
Email  jyotimagar2110@gmail.com  
 
Source of Monetary or Material Support  
Lokmanya tilak municipal medical college and general hospital,Mumbai,India. Pin:400022 
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [Nil] 
 
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 susheelkumar   Lokmanya tilak municipal medical college sion hospital mumbai,India   Gynaecology operation theatre 3rd floor hospital building
Mumbai
MAHARASHTRA 
8904744230

susheelkumarkembhavi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee human reasearch Lokamanya tilak municipal medical college &general hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N814||Uterovaginal prolapse, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  80.00 Year(s)
Gender  Male 
Details  Patient posted for elective vaginal hysterectomy
Expected duration of surgery is less than 4hrs
Patient is able to give informed written consent  
 
ExclusionCriteria 
Details  Any contraindications for spinal anaesthesia
Inability to understand or comply with the study protocol  
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare hemodynamics changes
To compare incidence of hypotension  
From the injection of spinal drug to end of surgery  
 
Secondary Outcome  
Outcome  TimePoints 
To compare vasoactive drug required to treat hypotension intra operative
To compare failure of spinal anaesthesia. 
From the injection of spinal drug to 24 hr post surgery  
 
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   N/A 
Date of First Enrollment (India)   31/12/2024 
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="1"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

patients will be enrolled for the study after detailed preoperative assessment and relevant investigation as per inclusion & exclusion criteria after obtaining written informed consent .

Anaesthesia will be given as  per usual standard protocol ,as per discretion of in charge anaesthetist . In the operative room, routine noninvasive monitoring, electrocardiogram, pulse oximete , Noninvasive Arterial Blood Pressure (NIBP) and nasal capnometer will be used. Baseline Pulse, BP, Respiratory rate, SpO2 will be checked and noted down. An intravenous access will be established and co loading with slow infusion of RL or NS 10 ml/kg will be started. Spinal anaesthesia will be given with 0.5% bupivacaine[H]) 15-17.5 mg with 10 ug fentanyl as per height and weight of patient & as per discretion of treating anaesthetist . SA will be  given in sitting position with 25-gauge Quincke spinal needle in L3–L4 or L4–L5 interspace after skin infiltration with lignocaine (2 ml, 2%) . After aspiration of cerebrospinal fluid, injection bupivacaine will be given either as single bolus dose technique in which patients will  receive a single bolus dose of bupivacaine over 10 s while in fractionated spinal anaesthesia technique , two-third of the total calculated dose will be given initially followed by one-third dose after 30 s gap , both doses given at a rate of 0.2 ml/s. .After injection of initial two-third dose, the syringe will be kept attached to the spinal needle for remaining 30 s, after which remaining one-third dose will be administered. Patients in both technique will be made supine immediately after spinal anesthesia . Then patient will be  monitored  for vital signs (heart rate and blood pressure)  continuously every 2 minutes till 10 minutes & then every 5 minutes for  30 minutes and then every 15 minutes till end of surgery .Sensory block will be  assessed by blunted needle method .Dermatome level tested every five minutes till thirty minutes, then every fifteen minutes until the point of regression of sensory level reached to L3 .At the end of 15 minutes of spinal anaesthesia , if sensory block failed to reach T8 level or if patient had pain due to inadequate block, it will  considered as failed block and general anaesthesia will be given and these patient will withdrawn from further analysis. patients who will receive single bolus dose spinal anaesthesia will be taken as Group B and patients who will receive fractionated spinal anaesthesia will be taken as Group F. We recorded various variable like  Anaesthesia readiness time: as time from the end of injection of spinal drug to the time sensory block reached T8 level and patient anaesthesia wise ready to be handed over to surgeon for surgery Degree of motor block: will be evaluated using a Modified Bromage scale (Bromage O: Free movement of limb at hip, knee and ankle joint. Bromage 1: Free movement of limb at knee and ankle joint. Bromage 2: Free movement limb at ankle joint. Bromage 3: No movement of limb at hip, knee and ankle joint).  Duration of motor block: noted as time from the onset of grade 3 motor block to complete resolution of motor block.

Duration of sensory block: will be noted as time from the onset of T8 sensory block to regression of sensory level to L3.  If patient required analgesia for mesenteric pull intraoperative ,will be given with IV fentanyl    1-2ug /kg  & it will noted as supplementation of analgesia intraoperative .  Clinically significant hypotension will be defined as decrease in systolic arterial pressure by 20% or more from baseline values or systolic < 90 mm of Hg or < 65 mean BP  .  Hypotension will be treated with IV ephedrine 5 mg or phenylephrine 50 ug incremental boluses dosages and the total amount of ephedrine or phenylephrine required will be noted down .   The number of hypotensive episodes and total vasopressor used will be recorded for each patient.  Clinically significant bradycardia is defined as a heart rate less than 50 beats per min and it will treated with IV atropine 0.5 mg boluses.  Incidences of clinically significant hypotension and bradycardia will noted as incidence of haemodynamic adverse event  All the patients will be monitored in post anaesthesia care unit till they will be shifted to general ward after they will fulfill PACU discharge criteria.  Time to demand first rescue analgesia after completion of surgery from the onset of T8 sensory level will noted as duration of analgesia .Rescue analgesia will be provided with IV tramadol 1-2 mg/Kg . Other adverse events like nausea or vomiting will be noted down will be treated with iV dexamethasone or with Inj. Ondansetron 4 mg i.v. Intraoperative blood loss will be noted down

 
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