| 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
|
|
|
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
|
|
|
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 |