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

Phase 3

Not yet recruiting

Conditions: Varicose veins of lower extremities with ulcer,

Registration Number: CTRI/2021/02/031086

Lead Sponsor: NA

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 64

Inclusion Criteria

PATIENTS GIVING WRITTEN INFORMED CONSENT AGED BETWEEN 18 YEARS TO 60 YEARS ASA GRADE I AND II.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PRIMARY OUTCOME PARAMETER IS GENE EXPRESSION	PRIMARY OUTCOME WILL BE ASESSED ON THE DAY OF SURGERY

Secondary Outcome Measures

Name	Time	Method
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 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

Trial Locations

Locations (1): KING GEORGES MEDICAL UNIVERSITY
🇮🇳
Lucknow, UTTAR PRADESH, India
KING GEORGES MEDICAL UNIVERSITY
🇮🇳Lucknow, UTTAR PRADESH, India
DR RAJNI GUPTA
Principal investigator
9839288980
rgkgmu@gmail.com