Prevention of low blood pressure in patients undergoing neck spine surgery for long-standing compression of spinal cord.
- Conditions
- Other spondylosis with myelopathy,
- Registration Number
- CTRI/2018/07/014970
- Lead Sponsor
- Anto Paul
- Brief Summary
Statement of ProblemDuring anaesthesia induction, cervical myelopathy patients have higher risk of developing hemodynamic changes due to ANS dysfunction and can result in spinal cord ischemia. Effect of fluid pre-loading on hemodynamics in patients with chronic cervical myelopathy during anaesthesia induction is unknown. Effect of post-induction hypotension on cSO2 is also unknown.
Aims and objectivesPrimary objective: To assess the effect of fluid pre-loading before induction of general anaesthesia, on the incidence of post-induction hypotension in patients with chronic cervical myelopathy
Secondary objective:
1. To assess the effect of fluid pre-loading before induction of general anaesthesia, on the hemodynamic parameters following induction in patients with chronic cervical myelopathy
2. To evaluate the effect of autonomic dysfunction on post induction hypotension and autonomic function changes during and following induction using the ANS index.
3. To assess effect of hypotension on cerebral oxygen saturation (cSO2).
Study procedurePatient details like age, sex, height, weight, BMI would be collected. Preoperative data including heart rate, Blood pressure, cardiac output, total peripheral resistance, blood oxygen saturation, ANS index, cerebral oxygen saturation would be collected using noninvasively placed patient monitors including NICOM, ANSiscope, and NIRS.
Following this patients in Group F would receive 20 ml/kg of Ringer lactate over 30 minutes prior to induction of anaesthesia, followed by 2ml/kg/h maintenance. Patients in Group C would receive Ringer lactate at 2ml/kg/h prior to induction of anaesthesia.
Standardized anaesthetic protocol will be followed for all patients for induction and maintenance of anaesthesia. Heart rate, Blood pressure, cardiac output, total peripheral resistance, blood oxygen saturation, ANS index, cerebral oxygen saturation would be collected before induction, at 1,3 and 5 minutes after induction, and 1,3 and 5 minutes after intubation and 5 minutes after positioning. Hypotension will be treated with mephentermine 3 mg boluses (repeated every 5 min) till blood pressure returns to normal range and documented. Other patient data in the perioperative period like duration of surgery, blood loss and blood transfusion details would also be collected
Anaesthesia managementPre-oxygenation will be done with a FiO2= 1.Anaesthesia will be induced with fentanyl (2mcg/kg), thiopentone (5mg/kg), preservative free lignocaine (1mg/kg).Muscle relaxation will be achieved with vecuronium (0.15mg/kg). Intubation will be done with appropriate size endotracheal tube at a minimum alveolar concentration of 1 MAC with a gaseous mixture of O2+air+Sevoflurane
Data collectionThe data collected would include the following:
Demographics
Nurick’s score for severity of cervical myelopathy
Pre-intervention HR, BP, spo2, ANS Index, CO, cSO2
Post study intervention HR, BP, spo2, ANS index, CO, cSO2
Post induction - HR, BP, spo2, ANS index, CO, cSO2
Post-intubation - HR, BP, spo2, ANS index, CO, cSO2
Post- positioning- HR, BP, spo2, ANS Index, CO, cSO2
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 60
- Evidence of cervical myelopathy clinically or on imaging studies for more than three months and posted for surgery 2. American Society of Anaesthesiologists Class 1.
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- AtlantoAxial Dislocation and Cervico-Medullary Junction lesion 2. Tumour pathology 3. Pre-existing systemic disease on treatment.
- Diabetes Mellitus, COPD, Hypertension, Ischemic heart disease, Cardiac dysfunction.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method hypotension after induction of general anaesthesia for surgery in patients with chronic cervical myelopathy Pre-intervention, Post-intervention, 1 minute after induction, 3 minutes after induction, 5 minutes after induction, 1 minute after intubation, 3 minutes after intubation, 5 minutes after intubation, 5 minutes after positioning for surgery
- Secondary Outcome Measures
Name Time Method Effect of hypotension on cerebral oxygen saturation (cSO2). Pre-intervention, Post-intervention, 1 minute after induction, 3 minutes after induction, 5 minutes after induction, 1 minute after intubation, 3 minutes after intubation, 5 minutes after intubation, 5 minutes after positioning for surgery Hemodynamic parameters following induction in patients with chronic cervical myelopathy Pre-intervention, Post-intervention, 1 minute after induction, 3 minutes after induction, 5 minutes after induction, 1 minute after intubation, 3 minutes after intubation, 5 minutes after intubation, 5 minutes after positioning for surgery. Effect of autonomic dysfunction on post induction hypotension and autonomic function changes during and following induction using the ANS index. Pre-intervention, Post-intervention, 1 minute after induction, 3 minutes after induction, 5 minutes after induction, 1 minute after intubation, 3 minutes after intubation, 5 minutes after intubation, 5 minutes after positioning for surgery
Trial Locations
- Locations (1)
National Institute of Mental Health And NeuroSciences.
🇮🇳Bangalore, KARNATAKA, India
National Institute of Mental Health And NeuroSciences.🇮🇳Bangalore, KARNATAKA, IndiaAnto PaulPrincipal investigator91-9446217922drantopaul@gmail.com