Studying the effect of intravenous dexmedetomidine on spinal anaesthesia with bupivacaine. Dexmedetomidine is an alpha agonist drug known to prolong the effects of spinal anaesthesia. Bupivacaine is a local anaesthetic.
- Conditions
- American Society of Anaesthesiologists Physical Status 1 or 2
- Registration Number
- CTRI/2015/01/005431
- Lead Sponsor
- Manipal University
- Brief Summary
Dexmedetomidine is a highly selective alpha2 agonist and studies have shown that it prolongs motor, sensory blockade during spinal anaesthesia without undesirable side effects.
The aim of our study is to compare the effect of 1 ug/kg of intravenous dexmedetomidine, given either as a bolus(1 ug/kg) or bolus plus infusion(0.5 ug/kg) on subarachnoid anaesthesia with 12.5 mg of hyperbaric bupivacaine(2.5 ml
of 0.5 % bupivacaine).
observer 1 is the anaesthesia faculty who will prepare the drug dilutions and observer 2 is the postgraduate(principal investigator, blinded to the study ) who will administer subarachnoid anaesthesia, record the parameters and any complications during the study.
On the day of surgey the patients are allocated into one of the 3 groups as per randomisation table.After shifting to the ot, monitors are attached, iv line secured and drugs will be administered as described previously.
All the parameters are then recorded till both sensory and motor recovery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 75
patients undergoing elective infraumbilical or lower limb surgery in the supine position under spinal anaesthesia belonging to american society of anaesthesiologists physical status 1 or 2.
Patients who do not consent for subarachnoid anaesthesia Patients with coagulopathy, hypovolaemia, BMI > 35 kg/m2, spinal abnormalities Chronic use of sedatives or antidepressants History of regular alcohol consumption Local infection over lumbar spine.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method onset of analgesia at T10. onset of analgesia at T10.sensory level then checked every 2 mins till | highest level of analgesia achieved then every 5 mins till end of 1 hr and every 15 mins till | 2 segment regression, recovery. | time of recovery at S2-3. | motor blockade assessed using modified bromage score.onset time is when bromage score of 3 is obtained and motor recovery when modified score is 0. | sedation score.sedation score recorded using ramsay sedation score every 15 mins throughout first 3 hrs. 2 segment regression. onset of analgesia at T10.sensory level then checked every 2 mins till | highest level of analgesia achieved then every 5 mins till end of 1 hr and every 15 mins till | 2 segment regression, recovery. | time of recovery at S2-3. | motor blockade assessed using modified bromage score.onset time is when bromage score of 3 is obtained and motor recovery when modified score is 0. | sedation score.sedation score recorded using ramsay sedation score every 15 mins throughout first 3 hrs. highest level of analgesia. onset of analgesia at T10.sensory level then checked every 2 mins till | highest level of analgesia achieved then every 5 mins till end of 1 hr and every 15 mins till | 2 segment regression, recovery. | time of recovery at S2-3. | motor blockade assessed using modified bromage score.onset time is when bromage score of 3 is obtained and motor recovery when modified score is 0. | sedation score.sedation score recorded using ramsay sedation score every 15 mins throughout first 3 hrs. recovery at S2-3. onset of analgesia at T10.sensory level then checked every 2 mins till | highest level of analgesia achieved then every 5 mins till end of 1 hr and every 15 mins till | 2 segment regression, recovery. | time of recovery at S2-3. | motor blockade assessed using modified bromage score.onset time is when bromage score of 3 is obtained and motor recovery when modified score is 0. | sedation score.sedation score recorded using ramsay sedation score every 15 mins throughout first 3 hrs. onset of motor block and recovery . onset of analgesia at T10.sensory level then checked every 2 mins till | highest level of analgesia achieved then every 5 mins till end of 1 hr and every 15 mins till | 2 segment regression, recovery. | time of recovery at S2-3. | motor blockade assessed using modified bromage score.onset time is when bromage score of 3 is obtained and motor recovery when modified score is 0. | sedation score.sedation score recorded using ramsay sedation score every 15 mins throughout first 3 hrs. sedation score. onset of analgesia at T10.sensory level then checked every 2 mins till | highest level of analgesia achieved then every 5 mins till end of 1 hr and every 15 mins till | 2 segment regression, recovery. | time of recovery at S2-3. | motor blockade assessed using modified bromage score.onset time is when bromage score of 3 is obtained and motor recovery when modified score is 0. | sedation score.sedation score recorded using ramsay sedation score every 15 mins throughout first 3 hrs.
- Secondary Outcome Measures
Name Time Method haemodynamic parameters-blood pressure, heart rate, saturation. other side effects like nausea, vomiting or pruritus BP and heart rate every 2.5 mins for first 15 mins.then 5 mins for first hour and then every 15 mins till complete recovery.
Trial Locations
- Locations (1)
Kasturba Medical College
🇮🇳Udupi, KARNATAKA, India
Kasturba Medical College🇮🇳Udupi, KARNATAKA, IndiaKavya R UpadhyaPrincipal investigator9986245389kavya.upadhya@gmail.com