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Comparing two drugs for reduced blood pressure changes in adult head and neck cancer patients undergoing free tissue flap operation

Comparison of Target Controlled Infusion (TCI) of Dexmedetomidine versus TCI propofol for head neck Cancer surgery with free flap reconstruction: A randomised clinical study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/02/104219
Enrollment
60
Registered
2026-02-18
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

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

Interventions

Intervention1: Target controlled infusion of dexmedetomidine: For the entire duration of free flap surgery, Medcaptain infusion pump shall be used to administer dexmedetomidine after selecting the Han

Sponsors

Dr Shagun Bhatia Shah
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Weighing 45-80kg, Undergoing head and neck cancer surgery with free-flap reconstruction

Exclusion criteria

Exclusion criteria: Patient refusal to give consent, Egg allergy, Bradyarrhythmias, Respiratory dysfunction, Hepatorenal dysfunction, Posted for redo surgery

Design outcomes

Primary

MeasureTime frame
Change in the mean arterial pressure from pre-induction levels levelsTimepoint: 1 min after endotracheal intubation—

Secondary

MeasureTime frame
Heart rateTimepoint: Baseline, On attaining set Ce, Pre-intubation, Intubation, 5min post intubation, pre-incision, incision, highest and lowest reading during resection, highest and lowest reading during anastomosis, 1min post reversal/end surgery;Mean arterial pressureTimepoint: Baseline, On attaining set Ce, Pre-intubation, Intubation, 5min post intubation, pre-incision, incision, highest and lowest reading during resection, highest and lowest reading during anastomosis, 1min post reversal/end surgery;Perfusion indexTimepoint: Baseline, On attaining set Ce, Pre-intubation, Intubation, 5min post intubation, pre-incision, incision, highest and lowest reading during resection, highest and lowest reading during anastomosis, 1min post reversal/end surgery;Total intraoperative fentanyl and consumptionTimepoint: 1 min post reversal/end surgery;Total intraoperative morphine consumptionTimepoint: 1 min post reversal/end surgery;Intraoperative sevoflurane consumptionTimepoint: 1 min post reversal/end surgery;Intraoperative study drug consumptionTimepoint: 1 min post reversal/end surgery;Blood lossTimepoint: 1 min post reversal/end surgery;Total amount of blood transfused intraoperativelyTimepoint: 1 min post reversal/end surgery;Total intraoperative colloidTimepoint: 1 min post reversal/end surgery;Total intraoperative crystalloidTimepoint: 1 min post reversal/end surgery;Major postoperative complicationsTimepoint: At the time of discharge from hospital—

Countries

India

Contacts

Public ContactDr Shagun Bhatia Shah

Rajiv Gandhi Cancer Institute and Research Centre, Sector 5, Rohini, Delhi

drshagun_2010@rediffmail.com09891769779

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026