The effect of Dexmedetomidine on recovery after General Anaesthesia- a randomized controlled study
- Conditions
- Patients undergoing elective surgery under general anaesthesia of expected duration less than 2 hours
- Registration Number
- CTRI/2018/03/012327
- Lead Sponsor
- Jawaharlal Institute of Postgraduate Medical Education Research
- Brief Summary
After informed consent, patients fulfilling the inclusion and exclusioncriteria will be randomized to two groups by computer generated random numbers.Pre operatively, psychomotor function of the patient will be assessed with TDTand DSST. Trieger dot test consists of joining 30 dots with a line to form afigure within a time limit of 60 seconds. It is analyzed by number of dotsmissed, maximum distance of dots missed and average number of dots missed. DSSTconsists of matching digits with their corresponding symbol within a timelimit. The digits along with the corresponding symbols will be located in alegend given at the top of the page. 9 such digits will be assigned symbols inthe legend. It is analyzed by the number of digits correctly matched with thecorresponding symbols within 90 seconds. On the day before surgery, both thetests will be done thrice to familiarize it to the patient and fourth test willbe taken as the baseline psychomotor evaluation for that patient. In each of these patients, after attaching the routine monitors andrecording baseline parameters, anaesthesia will be induced with Propofol (up to2.5 mg/kg) and Fentanyl (2µg/kg). Vecuronium (0.1mg/kg) will be given in bothgroups and trachea intubated after 3 minutes. Dexmedetomidine will be dilutedto 2µg/ml in a total volume of 50 ml and will be blinded against an identicalvolume of saline. After intubation, each patient’s receive a loading dose of0.5 ml/kg over 10 minutes & a maintenance infusion of 0.25ml/kg/hr.Anesthesia will be maintained by nitrous oxide 67% in oxygen and sevofluranewhose MAC value will be adjusted to maintain an entropy value of 40 - 60. Supplementalfentanyl will be given as clinically indicated. Fentanyl will not beadministered within 30 min of the end of surgery. Inhalational agents and infusions will be stopped atthe time of skin closure. TDT and DSST will be conducted at intervals of 30 minutes, 60 minutes,90 minutes and 120 minutes after the end of the surgery. The clinicianperforming the postoperative psychomotor analysis would be unaware of the drugthat had been administered to the patient.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 90
ASA 1 & 2 patients undergoing elective surgery of expected duration less than 2 hrs under general anaesthesia.
Patients refusing consent, known history of psychiatric illness, chronic drug or alcohol abuse, known hypersensitivity to drugs used, family history of malignant hyperthermia, significant cardiopulmonary, hepatic or renal disease, pregnant and breast feeding women, hypertensive patients not on any treatment or those treated with alpha or beta blockers and patients on concurrent sedative medications.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Psychomotor function was assessed by Trieger dot test (TDT) and Digit symbol substitution test (DSST). Both the tests were done pre-operatively (baseline), 30 minutes, 60 minutes, 90 minutes and 120 minutes after extubation.
- Secondary Outcome Measures
Name Time Method Total opioid requirement Fentanyl 1 µg/kg was supplemented whenever there was increase in patients heart rate or blood pressure by 30% from baseline in both the groups during surgery
Trial Locations
- Locations (1)
Jawaharlal Institute of Postgraduate Medical Education & Research
🇮🇳Pondicherry, PONDICHERRY, India
Jawaharlal Institute of Postgraduate Medical Education & Research🇮🇳Pondicherry, PONDICHERRY, IndiaDr Ayyappan CPrincipal investigator9894696456ayyappan.ibu@gmail.com