Comparison of Intravenous Ketodex Versus Fentanyl for better control of blood pressure and heart rate in Patients Undergoing Endoscopic Transnasal Transsphenoidal Pituitary Surgery

To Compare the Efficacy of Intravenous Ketodex Versus Fentanyl for Hemodynamic Stability in Patients Undergoing Endoscopic Transnasal Trans Sphenoidal Pituitary Surgery: A Randomized Study - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/04/084090

Enrollment

Registered

2025-04-03

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-28

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

Conditions

Health Condition 1: C719- Malignant neoplasm of brain, unspecified Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: Ketodex: GROUP KETODEX: Patients will be administered IV infusion of 0.5mg/kg ketamine and 1mcg/kg dexmedetomidine for 10 minutes before anaesthesia induction in separate syringes. Afte

Eligibility

Inclusion criteria

Inclusion criteria: American Society of Anesthesiologists (ASA) physical status classification of I or II Scheduled for elective endoscopic transnasal transsphenoidal (TNTS) resection of a pituitary tumor

Exclusion criteria

Exclusion criteria: Non consenting patient Anticipated difficult airway Preoperative heart rate of less than 50 beats per minute Presence of any degree of heart block or other cardiac comorbidities Current use of beta blocker Pregnant or nursing women Use of antihypertensive medications History of pituitary apoplexy Known allergy to the study drug Patients who cannot be extubated

Design outcomes

Primary

Measure	Time frame
To estimate and compare intraoperative Mean arterial pressure (MAP) and Heart rate (HR) at different stages of surgery in both the groups.Timepoint: Baseline Before intubation After intubation Before adrenaline-soaked nasal packing After adrenaline-soaked nasal packing Sphenoid dissection Sellar ridge dissection Post extubation (0 min) Post extubation (5 mins) Post extubation (arrival to ICU)	—

Secondary

Measure	Time frame
To estimate and compare the emergence time between the groupsTimepoint: End of surgery;To estimate and compare the post operative visual analogue scale (VAS) score between the groupsTimepoint: just after extubation, 2 hours ,4hours ,6 hours ,12hours and 24 hours post extubation;To estimate and compare the time point for the first ask of analgesic after extubation between the groupsTimepoint: Post operative period upto 24 hours;To estimate and compare patient satisfaction score using 5 points Likert s scale in both the groupsTimepoint: 24 hours after extubation;To estimate and compare the surgical field quality using Fromme s score in both the groupsTimepoint: End of surgery	—

Measure

Time frame

To estimate and compare the emergence time between the groupsTimepoint: End of surgery;To estimate and compare the post operative visual analogue scale (VAS) score between the groupsTimepoint: just after extubation, 2 hours ,4hours ,6 hours ,12hours and 24 hours post extubation;To estimate and compare the time point for the first ask of analgesic after extubation between the groupsTimepoint: Post operative period upto 24 hours;To estimate and compare patient satisfaction score using 5 points Likert s scale in both the groupsTimepoint: 24 hours after extubation;To estimate and compare the surgical field quality using Fromme s score in both the groupsTimepoint: End of surgery

—

Countries

India

Contacts

Public ContactAshutosh Kaushal

AIIMS Bhopal

drashutosh.kaushal@gmail.com9599156154

Outcome results

None listed

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