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A clinical trial to study the effect of two drugs Propofol-Dexmedetomidine and Ketofol-Dexmedetomidine in recovery from anesthesia among patients undergoing endoscopic trans-spenoidal pituitary surgeries

Comparison of intraoperative Propofol-Dexmedetomidine and Ketofol-Dexmedetomidine infusions on recovery from anesthesia in patients undergoing endoscopic trans-spenoidal pituitary surgeries.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/04/033240
Enrollment
40
Registered
2021-04-29
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: D337- Benign neoplasm of other specifiedparts of central nervous system Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: ketofol: ketofol (1:5) for maintenance of anaesthesia in 0.6-0.9 ml/kg/hr durinig trans sphenoidal pituitary surgery Control Intervention1: propofol: Emergence and recovery from anaesth

Sponsors

INSTITUTION PGIMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Age 18-65 years • ASA I and II • Either sex • Undergoing transsphenoidal pituitary surgery

Exclusion criteria

Exclusion criteria: • ASA III or more • Pituitary apoplexy • Redo surgeries • Psychiatric illness • Ischemic heart disease • Anticipated difficult airway • Pregnant patient • Patient allergic to the study drug • Patient not giving consent to participate in the study

Design outcomes

Primary

MeasureTime frame
To compare the time of recovery from anesthesia among the study participants receiving Propofol-dexmedetomidine or Ketofol-dexmedetomidine for maintenance of anesthesiaTimepoint: After extubation when the patient recalls his name will be taken as the recovery time—

Secondary

MeasureTime frame
Effect of anaesthetic agents on i. Intraoperative hemodynamic parameters (SBP, MAP, HR) including at the time of recovery and extubation ii. Intraoperative regional cerebral oxygenation (NIRS) including at the time of recovery and extubation iii. Emergence time and Emergence characteristics iv. Extubation time v. Orientation and cognition in immediate postoperative period vi. Quality of surgical field using Likertâ??s scale by operating Surgeon vii. Postoperative pain viii. PONV Timepoint: hemodyanmic parameters and nirs at Baseline, 0 ,1020,30,40,50,60,70,80,90,100,110,120,130,140,150,160,170,180,preintubation, postintubation, infiltration, incision,disscection, discontinuation of anesthesia, discontinuation of nitrous, emergence, extubation,recovery orientation and cognition - 10 mins post extubation, recoverycharacteristics : 10,15 mis after extuabtion,Pain - 60 mins after extubation, PONV - 5,10,60 mins after extubation—

Countries

India

Contacts

Public ContactDr Nidhi Panda

Postgraduate Institute of Medical Education and Research

nidhibp@gmail.com7087009525

Outcome results

None listed

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