Health Condition 1: J320- Chronic maxillary sinusitis
Conditions
Interventions
Intervention1: Dexmedetomidine infusion for controlled hypotension during Functional Endoscopic Sinus Surgery (FESS): Loading dose 1 microgram per kilogram IV over 10 minutes, followed by maintenance
Sponsors
Government Mohan Kumaramangalam Medical College and Hospital Salem
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults aged 18 to 65 years. 2. Patients scheduled for elective Functional Endoscopic Sinus Surgery FESS under general anaesthesia. 3. American Society of Anesthesiologists ASA physical status I and II. 4. Body mass index BMI less than 35 kilogram per metre square. 5. Ability to understand the study and provide written informed consent. 6. Baseline sinus rhythm on ECG no pre existing high grade atrioventricular block. 7. No contraindication to either study drug dexmedetomidine or propofol as judged by the investigator. 8. Expected duration of surgery greater than or equal to 30 minutes so controlled hypotension period is meaningful.
Exclusion criteria
Exclusion criteria: 1. Patients refusing or unable to give informed consent. 2. ASA physical status III and above. 3. Allergy or hypersensitivity to dexmedetomidine, propofol, or any study drugs. 4. Patients with uncontrolled hypertension, ischemic heart disease, severe cardiac arrhythmias, or congestive heart failure. 5. Presence of advanced heart block second/third degree or severe bradycardia HR less than 50 per min. 6. Patients with chronic renal failure or hepatic dysfunction. 7. Patients with coagulopathy or on anticoagulant therapy. 8. Pregnant or lactating women. 9. Patients with history of epilepsy, psychiatric illness, or substance abuse. 10. Patients with difficult airway anticipated e.g. limited mouth opening, craniofacial anomalies. 11. Emergency surgeries or procedures expected to require conversion to open surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of surgical field graded by the surgeon using a validated scale.Fromme Boezaart Surgical Field Bleeding Score Timepoint: 1.Baseline 2.Intraoperatively every 10 mins till end of surgery 3. At the end of surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To compare the intraoperative haemodynamic stability heart rate, mean arterial pressure between dexmedetomidine & propofol infusion groups. 2. To assess the intraoperative blood loss in both groups. 3. To evaluate the requirement of rescue drugs vasopressors, anticholinergics, additional analgesics during surgery. 4. To compare the time to extubation & recovery profile between the two groups. 5. To assess the postoperative analgesic requirement & sedation scores. 6. To evaluate the incidence of adverse events bradycardia, hypotension, nausea, vomiting, delayed recovery. 7. To compare surgeon satisfaction scores regarding surgical field visibility. Timepoint: 1.Baseline 2.Intraoperatively Every 10 mins 3. At the end of surgery. | — |
Countries
India
Contacts
Public ContactVeeresh Ragunathan
Outcome results
None listed