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Comparing Dexmedetomidine and Propofol infusion as added anesthetic drugs in patients undergoing Trans nasal Trans sphenoidal excision of pituitary tumor surgeries

Comparison of effect of Dexmedetomidine infusion and Propofol infusion as anesthetic adjuvants in patients undergoing Trans Nasal Trans Sphenoidal Resection of Pituitary Tumors

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/07/026811
Enrollment
40
Registered
2020-07-27
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: D3A8- Other benign neuroendocrine tumors

Interventions

Intervention1: Dexmedetomidine Infusion: A loading dose of the Dexmedetomidine infusate (1.0 mcg/kg for 10 min) is followed by a maintenance infusion of 0.5 mcg/kg/hr Dexmedetomidine is an alpha-2 ad

Sponsors

Amrita Institute of Medical Sciences and Research Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: American Society of Anesthesiologists (ASA) physical status 1 to 2 Age between 18 and 65 years Scheduled for elective TNTS resection of pituitary tumor.

Exclusion criteria

Exclusion criteria: Patients with ASA status 3, 4, and 5 Preoperative Glasgow Coma Scale less than 15 Preoperative HR less than 50/min Patients on Beta Blockers Heart block of any degree and/or any other cardiac comorbidities Known allergy to Dexmedetomidine and Propofol Refusal to give consent

Design outcomes

Primary

MeasureTime frame
Heart Rate (beats/min), Systolic Blood Pressure (mmHg), Diastolic Blood Pressure (mmHg), Mean Arterial Pressure (mmHg), EtISO (v/v %), Bispectral Index Score (BISS), Quality of Surgical Field (4-point scale), Use of Inotropic Supports (frequency and dosage), Fluid Intake (mL), Urine Output (mL), Estimated Blood Loss (mL), Time to Emergence (minutes), Time To Extubation (minutes)Timepoint: (i) baseline; (ii) after intubation; (iii) before and (iv) after nasal packing with saline swabs soaked in adrenaline; (v) before and (vi) after nasal speculum (Hardyââ?¬â?¢s self-retaining speculum) placement; during (vii) sphenoid dissection; (viii) sellar ridge dissection; (ix) at the time of stoppage of the volatile anesthetic agent (isoflurane); (x) immediately following extubation Similarly EtISO is noted from time (ii) to time (ix) and BISS values from time (ii) to time (ix).—

Secondary

MeasureTime frame
Modified Aldrete Score (out of 10) Verbal Descriptive Scale To Assess Postoperative Nausea and Vomiting (0-3), Visual Analogue Scale to Assess Pain (1-10)Timepoint: At ICU arrival and then every 60 minutes for initial 6 hours.—

Countries

India

Contacts

Public ContactDr Pawan Kumar

Amrita Institute of Medical Sciences and Research Centre

gokuldas75@hotmail.com9847448005

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026