Comparison of two different drugs as Adjuvants in spinal anesthesia for Abdominal Hysterectomy surgeries.
- Conditions
- Medical and Surgical,
- Registration Number
- CTRI/2022/01/039437
- Brief Summary
Patients planned for elective procedures will be approached prior to the study and patient information sheet will be given
Pre-anaesthetic checkup will be done on the day before surgery.
An informed consent will be taken, and patient will be kept nil per oral for 6 hours prior to surgery.
Premedication with T. Pantoprazole 40mg, T. Metoclopramide 10mg and T. Alprazolam 0.25mg will be given on the previous night and in the morning.
The visual analogue system will be explained to all patients.
IV access will be secured before the procedure. Preloaded with ringer lactate 500ml.
Vital parameters will be monitored before and during the surgery using pulse oximetry, BP , continuous ECG, etc.
Baseline hemodynamic parameters will be measured (SBP, MAP, HR, DBP)
Inj. Ondansetron(4mg) and Inj. Midazolam(1 mg) will be administered IV 15 minutes prior to surgery.
Spinal anaesthesia to be administered with the patients in left lateral position at L3L4 space with 23-25 gauge spinal needle.
The drug to be loaded and handed over by one person not related to the study.
Group 1-patients to receive 0.5% bupivacaine 3ml with 0.5ml (25µg) fentanyl
Group 2- patients to receive 0.5% bupivacaine 3ml with 0.5ml (10µg) dexmedetomidine
intraoperatively monitoring of blood pressure, pulse rate and saturation done at 5,10,15,20,25 and 30min after injection and subsequently every 15 min.
Onset of sensory blockade and onset of complete motor blockade to be recorded
Sensory block assessed by pinprick method
motor block assessed by Modified Bromage scale
Duration of sensory and motor blockade to be noted
Postoperatively pain score(VAS) assessed at 1hr for first 4h and at 6,12and24h; rescue analgesics will be given when VAS score is more than 4 or on patient request for pain relief; duration of analgesia to be noted.
Any fall in heart rate below 50/min to be treated with atropine 0.6mg
Fall in systolic blood pressure below 20% of the baseline to be managed with inj. Ephedrine 6 mg in increments.
Any signs of respiratory depression noted to be dealt with oxygen supplementation and assisted ventilation.
Data collected will be entered on study proforma
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Female
- Target Recruitment
- 50
PATIENTS OF ASA STATUS 1 & 2.
1.PATIENT REFUSAL 2.PATIENT ON ALPHA BLOCKERS, BETA BLOCKERS DRUGS 3.PATIENT SENSITIVE OR ALLERGIC TO STUDY MEDICATIONS 4.PATIENTS OF ASA STATUS 3 & 4.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method TIME OF RESCUE ANALGESIA VAS SCORE ASSESSED AT 1hr 2hr 3hr 4hr 6hr 12hr 24hr | RESCUE ANALGESIA GIVEN WHEN VAS SCORE MORE THAN 4 OR ON PATIENT REQUEST | TIME IN MINUTES NOTED | DURATION OF ANALGESIA NOTED
- Secondary Outcome Measures
Name Time Method TIME OF ONSET OF SENSORY BLOCK BY PIN PRICK METHOD HEART RATE 5,10,15,20,25 and 30min after injection and subsequently every 15 min. TIME OF ONSET OF MOTOR BLOCK BY MODIFIED BROMAGE SCALE SPO2 5,10,15,20,25 and 30min after injection and subsequently every 15 min. DURATION OF SENSORY BLOCK GRADE 2 ON PIN PRICK DURATION OF MOTOR BLOCK MODIFIED BROMAGE SCALE SCORE 0 SYSTOLIC AND DIASTOLIC BLOOD PRESSURE 5,10,15,20,25 and 30min after injection and subsequently every 15 min.
Trial Locations
- Locations (1)
PUSHPAGIRI INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE
🇮🇳Pathanamthitta, KERALA, India
PUSHPAGIRI INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE🇮🇳Pathanamthitta, KERALA, IndiaVIJITHA BABYPrincipal investigator9446801383vijithababy10@gmail.com