A comparison of two drugs effect (Dexmedetomidine versus Magnesium sulphate) on postoperative delirium in patients undergoing head and neck oncological surgeries

A comparative study on the effect of Dexmedetomidine versus Magnesium sulphate on postoperative delirium in the patients undergoing head and neck oncological surgeries- A prospective randomized study - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/10/096005

Enrollment

Registered

2025-10-13

Start date

Unknown

Completion date

Unknown

Last updated

2025-11-17

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: Dexmedtomidine: Intravenous loading dose with 1mcg/kg over 10 minutes and infusion 0.5mcg/kg till the end of surgery Control Intervention1: Magnesium Sulphate: Intravenous 30 mg/kg over

Eligibility

Inclusion criteria

Inclusion criteria: ASA physical status I and II Planned for head and neck oncological surgery

Exclusion criteria

Exclusion criteria: Patient with psychological disorder Patient with history of stroke or cognitive dysfunction Patient with inability to communicate (coma, language barrier, deaf ) Chronic or acute intake of sedative or anticonvulsant drug Patients with severe cardiac dysfunction, renal or hepatic dysfunction Bradycardia (Heart rate less than 50 bpm) Allergy to study drugs Surgical duration more than 6 hours

Design outcomes

Primary

Measure	Time frame
To assess postoperative delirium using CAM-ICU score in patients undergoing head and neck surgeries in dexmedetomidine and magnesium sulphate groupTimepoint: Postoperative day 2(T1) Postoperative day 5 (T5)	—

Secondary

Measure	Time frame
To monitor effects of dexmedetomidine and magnesium sulphate on heart rate and BP IntroperativelyTimepoint: Baseline(T0) Post loading dose (T1) Intraoperative period every hourly;To record total dose of intraoperative fentanyl used to evaluate opioid -sparing effect of each agentTimepoint: At the end of surgery;To assess the sleep quality using Richard Campbell Sleep QuestionnaireTimepoint: Postoperative day 2 Post operative day 5	—

Measure

Time frame

To monitor effects of dexmedetomidine and magnesium sulphate on heart rate and BP IntroperativelyTimepoint: Baseline(T0) Post loading dose (T1) Intraoperative period every hourly;To record total dose of intraoperative fentanyl used to evaluate opioid -sparing effect of each agentTimepoint: At the end of surgery;To assess the sleep quality using Richard Campbell Sleep QuestionnaireTimepoint: Postoperative day 2 Post operative day 5

—

Countries

India

Contacts

Public ContactDr Harish Kumar

AIIMS, Bhopal

harish.anesth@aiimsbhopal.edu9471300943

Outcome results

None listed

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