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Using either ketodex or ketofol to prevent distress while waking up from anaesthesia after transsphenoidal pituitary surgery

Effect of single bolus dose of ketodex and ketofol on emergence agitation in patients undergoing transphenoidal pituitary surgery: A prospective double blinded randomized clinical trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/06/054315
Enrollment
80
Registered
2023-06-22
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

Health Condition 1: O- Medical and Surgical Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: Intravenous administration of either ketodex or ketofol: Intravenous adnministration of either fixed dose ketodex or fixed dose ketofol approximately ten minutes prior to surgery comple

Sponsors

Sanjay Gandhi Post Graduate Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Adult patients (18-65 years) 2.Either gender 3.Scheduled for elective transsphenoidal pituitary surgeries. 4. American Society of Anaesthesiologists (ASA) Class I / II. 5.Body Mass Index (BMI) (22-28kg/m²)

Exclusion criteria

Exclusion criteria: 1.Patients unable (legally incompetent) or unwilling to give consent. 2.Patient with difficult airway. 3.Previous history of psychiatric, anxiety or post-traumatic stress disorders. 4.History of allergy to study drugs. 5.Patient on sedative or hypnotic medication. 6.Patients with chronic pain or on painkiller. 7.Patients with severe hepatic or kidney disorders. 8.Patients having a history of thyrotoxicosis, hypertension or cardiac disorders. 9.Patients on chronic beta blockers. 10.Pregnant or breast feeding females

Design outcomes

Primary

MeasureTime frame
Sedation score (Riker Sedation -Agitation Score Scale)Timepoint: Every ten minutes for the first hour following surgery—

Secondary

MeasureTime frame
Emergence TimeTimepoint: Time between stoppage of sevoflurane to obeying verbal commands;Vital parameters like heart rate, systolic blood pressure, diastolic blood pressure & mean blood pressureTimepoint: Every ten minutes for the first hour following surgery;Pain scores based on Visual Analogue ScaleTimepoint: Every ten minutes for the first hour following surgery;Adverse events like vomiting, nausea, bradycardia etc.Timepoint: Every ten minutes for the first hour following surgery;Time to achieve a Modified Aldrete Score of 9 or moreTimepoint: From the time of shifting to Post Anaesthesia care unit to achieving the score—

Countries

India

Contacts

Public ContactKancharala Avinash

Sanjay Gandhi Institute of Medical Sciences

rudrashish@yahoo.com9256543256

Outcome results

None listed

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