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Effect of giving anaesthesia without opioids on post-operative disorientation in patients undergoing surgeries for oral cancers

Effect of opiate-free anaesthesia on post-operative delirium in patients undergoing free-flap surgeries for oral cancers

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/06/043561
Enrollment
64
Registered
2022-06-29
Start date
Unknown
Completion date
Unknown
Last updated
2022-08-02

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

Conditions

Health Condition 1: C10- Malignant neoplasm of oropharynx Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: Ketamine and dexmeditomidine infusions.: One group of patients will receive ketamine 0.5-1mg/kg/h and dexmeditomidine 0.3-0.7mcg/kg/h infusions Control Intervention1: Intravenous morphi

Sponsors

Amrita Institute of Medical Sciences Kochi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients undergoing free-flap surgeries for oral cancer reconstruction 2. All ASA-PS grades

Exclusion criteria

Exclusion criteria: 1. Patients with known hypersensitivity to alpha-adrenoreceptor agonists or ketamine, 2. Patients with known psychiatric illnesses, 3. Patients with history of emergence delirium after ketamine administration, 4. Unplanned re-exploration surgeries with opiates are excluded.

Design outcomes

Primary

MeasureTime frame
To compare the occurence of post-operative delirium upto 72 hours between opiate and opiate-free anaesthesia groups in oral cancer patients undergoing major resection and reconstruction surgeriesTimepoint: upto 72 hours post-operatively

Secondary

MeasureTime frame
1. To compare the intraoperative haemodynamics between the two groupsTimepoint: Intraoperatively;2. To analyse the effect of ASA grading on occurence of post-operative deliriumTimepoint: First five consecutive post-operative days;3. To evaluate the occurence of post-operative delirium in the subgroup of tracheostomised patientsTimepoint: First five consecutive post-operative days;4. To study the relationship between age and occurence of post-operative deliriumTimepoint: First five consecutive post-operative days;5. To identify factors predisposing to post-operative deliriumTimepoint: Perioperative

Countries

India

Contacts

Public ContactDr Rachita Ajit Naik

Amrita Institute of Medical Sciences, Kochi

drjerrypaul@gmail.com9048699161

Outcome results

None listed

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