| CTRI Number |
CTRI/2021/02/031086 [Registered on: 08/02/2021] Trial Registered Prospectively |
| Last Modified On: |
06/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparision of monitored anaesthesia care(a type of sedation ) with spinal anaesthesia in day care varicose vein surgery and its effect on stress gene expression |
|
Scientific Title of Study
|
COMPARISON OF MONITORED ANAESTHESIA CARE WITH SPINAL ANAESTHESIA IN DAY CARE VARICOSE VEIN SURGERY AND ITS EFFECT ON STRESS GENE EXPRESSION |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR NANNAM SPANDANA |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
KING GEORGES MEDICAL UNIVERSITY |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY KGMU LUCKNOW
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9494426386 |
| Fax |
|
| Email |
spandananannam93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RAJNI GUPTA |
| Designation |
PROFESSOR |
| Affiliation |
KING GEORGES MEDICAL UNIVERSITY |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
KGMU LUCKNOW
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9839288980 |
| Fax |
|
| Email |
rgkgmu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR RAJNI GUPTA |
| Designation |
PROFESSOR |
| Affiliation |
KING GEORGES MEDICAL UNIVERSITY |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
KGMU LUCKNOW
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9839288980 |
| Fax |
|
| Email |
rgkgmu@gmail.com |
|
|
Source of Monetary or Material Support
|
| KING GEORGES MEDICAL UNIVERSITY |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| 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 RAJNI GUPTA |
KING GEORGES MEDICAL UNIVERSITY |
DEPARTMENT OF ANAESTHESIOLOGY
KGMU LUCKNOW
Lucknow
UTTAR PRADESH |
9839288980
rgkgmu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KING GEORGES MEDICAL UNIVERSITY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I830||Varicose veins of lower extremities with ulcer, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
COMPARISION OF MONITORED ANAESTHESIA CARE WITH SPINAL ANAESTHESIA |
MONITORED ANAESTHESIA WITH DEXMEDITOMIDINE(INFUSION)
DOSE : LOADING DOSE 0.1 mcg / kg OVER 10 MINUTES f/b MAINTAINANCE DOSE 0.2-0.6 mcg/kg/hr
ROUTE OF ADMINISTRATION :INTRAVENOUS
FREQUENCY : VIA INFUSION
DURATION OF THERAPY : DEPENDS UPON DURATION OF SURGERY (45 MINUTES - 2 HOURS) |
| Intervention |
MONITORED ANAESTHESIA CARE AND SPINAL ANAESTHESIA |
SPINAL ANAESTHESIA WITH ROPIVACAINE 0.5 %
DOSE : 10 mg -15 mg
ROUTE OF ADMINISTRATION :INTRATHECAL
FREQUENCY : 0.2 ML/SEC
DURATION OF THERAPY : DEPENDS ON DURATION OF SURGERY ( 45 MINUTES - 2 HOURS ) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
PATIENTS GIVING WRITTEN INFORMED CONSENT
AGED BETWEEN 18 YEARS TO 60 YEARS
ASA GRADE I AND II |
|
| ExclusionCriteria |
| Details |
REFUSAL OF PATIENTS
PATIENTS UNDERGONE GENERAL ANAESTHESIA WIHIN 7 DAYS , HAD TAKEN ALPHA-2 AGONIST WITHIN 14 DAYS
PATIENTS WHO HAD EXPERIENCED ACUTE STABLE ANGINA OR MYOCARDIAL INFARCTION WITHIN PREVIOUS 6 WEEKS
PATIENTS WITH LIVER CIRRHOSIS , THROMBOCYTOPENIA,COAGULOPATHIES,THIRD DEGREE HEART BLOCK AND CONTRAINDICATION FOR NEURAXIAL BLOCK
SEVERE BRADYCARDIA,AND SYSTOLIC BLOOD PRESSURE LESSTHAN 90 MM HG
PREGNANT FEMALE
CURRENT PSYCHIATRIC DISORER
KNOWN DRUG ALLERGY TO THE STUDY DRUGS
ASA GRADE III AND IV |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| PRIMARY OUTCOME PARAMETER IS GENE EXPRESSION |
PRIMARY OUTCOME WILL BE ASESSED ON THE DAY OF SURGERY |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
TO EVALUATE THE SEDATIVE AND ANAGLGESIC EFFECT OF DEXMEDETOMIDINE DURING MONITORED ANAESTHESIA CARE IN VARICOSE VEIN SURGERY
TO STUDY THE LOCAL ANAESTHETIC EFFECT OF ROPIVACAINE IN SPINAL ANAESTHESIA IN VARICOSE VEIN SURGERY
TO INVESTIGATE THE MODULATION OF STRESS GPX3 GENES WITH EXPOSURE TO TWO ANAESTHESIA TECHNIQUES
|
AT BASELINE AND AFTER SURGERY |
TO COMPARE THE INTRAOPERATIVE HEMODYNAMIC CHANGES IN BETWEEN MONITORED ANAESTHESIA CARE WITH DEXMEDETOMIDINE AND SPINAL ANAESTHESIA WITH ROPIVCAINE
TO ASSESS THE POST OPERATIVE RECOVERY STATUS OF PATIENTS IN TERMS OF EARLY AMBULATION |
AT BASELINE AND DURING THE PERIOD OF SURGERY |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
22/02/2021 |
| 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="0"
Days="0" |
|
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
|
THIS STUDY IS RANDOMISED CONTROLLED TRIAL COMPARING THE SAFETY AND EFFICACY OF MONITORED ANAESTHESIA CARE USING DEXMEDETOMIDINE WITH SPINAL ANAESTHESIA USING ROPIVACAINE IN VARICOSE VEIN SURGERY AND TO INVESTIGATE THE MODULATION OF STESS GPX3 GENES WITH EXPOSURE TO TWO ANAESTHESIA TECHNIQUES.
DEXMEDETOMIDINE PRODUCES DOSE DEPENDENT SEDATION , ANXIOLYSIS , ANALGESIC AND NARCOTIC SPARING EFFECT AND ENABLES PATIENTS TO RESPOND TO VERBAL STIMULI DURING SURGERY WITHOUT SIGNIFICANT RESPIRATORY DEPRESSION .
ROPIVACAINE IS LONG ACTING AMIDE LOCAL ANAESTHETIC AGRNT WHICH IS LESS LIPHOPHILIC RESUTING ON REDUCED MOTOR BLOCKADE WITH GREATER DEGREE F MOTOR-SENSORY DIFFERENTIATION WHICH WILL BE USEFUL WHEN MOTOR BLOCKADE IS UNDESIRABLE.
THIS STUDY HELPS ANAESTHETIST TO DECIDE THE BEST TECHNIQUE TO BE PERFOMED FOR VARICOSE VEIN SURGERY WHICH IS A DAY CARE SURGERY AND WHERE LESS HAEMODYNAMIC CHANGES ARE EXPECTED INTRA OPERATIVELY AND EARLY MOBILIZATION IS REQUIRED POST OPERATIVELY. |