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Comparison of two drugs Dexmedetomidine and Magnesium Sulphate to reduce bleeding in surgical field during FESS surgeries.

To assess the quality of surgical field during FESS surgeries: Comparison of Dexmedetomidine with Magnesium Sulphate: A randomised clinical study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/04/042142
Enrollment
80
Registered
2022-04-25
Start date
Unknown
Completion date
Unknown
Last updated
2022-05-02

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

Conditions

Health Condition 1: J32- Chronic sinusitis Health Condition 2: J341- Cyst and mucocele of nose and nasal sinus Health Condition 3: J342- Deviated nasal septum Health Condition 4: J343- Hypertrophy of nasal turbinates Health Condition 5: J33- Nasal polyp Health Condition 6: J348- Other specified disorders of noseand nasal sinuses Health Condition 7: J349- Unspecified disorder of nose and nasal sinuses

Interventions

Intervention1: Inj. Dexmedetomidine: Creation of bloodless surgical field with hypotenisve anaesthesia using induction loading dose of 1µg/kg in 50 ml of 0.9% saline solution over 15 min before induc

Sponsors

GMERS Medical College and Hospital Gotri Vadodara
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1 Patients who will give consent for undergoing elective Functional Endoscopic Sinus Surgery under General Anesthesia 2 Patients aged between 20 and 60 years 3 Patients with BMI ranging 19-27. 4 Patients with American Society of Anesthesia physical status 1 and 2

Exclusion criteria

Exclusion criteria: 1 History of allergy to study drugs. 2 Altered Prothrombin Time, Partial Thromboplastin Time or International Normalized Ratio or other coagulation abnormalities 3 Pregnancy, haemoglobin level lower than 10 mg/dL 4 K/C/O of HT, IHD, valvular heart disease. 5 Acute and chronic renal failure, cerebrovascular diseases, neuromuscular disorders, deep vein thrombosis and any other known systemic or psychiatric disorders 6 Cerebro-Orbital involvement and Revision mucormycosis related FESS surgeries.

Design outcomes

Primary

MeasureTime frame
The bloodless field established using the studys drug to surgeons satisfactionTimepoint: Change in SBP, DBP, MAP at time after starting infusion of study drug being taken as T0. T1 - After infusion is over T2 - Immediately after intubation T3 - 3 minutes after start of surgery T4 - 10 minutes after T5 - 30 minutes after T6 - 45 minutes after T7 - 60 minutes after T8 - 75 minutes after T9 - 90 minutes after T10 - Every 15 minutes after T11 - At end of surgery T12 - After extubation—

Secondary

MeasureTime frame
Post operative recovery of patientsTimepoint: Change in SBP, DBP, MAP, pulse, Spo2 postoperatively T13 - After extubation T14 - 15 minutes after T15 - 30 minutes after T16 - 60 minutes after T17 - 90 minutes after Alongwith assessment of sedation by Ramsays Sedation Scale and Modified Aldrette Score after extubation. Also Nausea Vomiting scale and complications to be added.;Stability of patients vital parameters Timepoint: Change in SBP, DBP, MAP, Pulse, Spo2,etc at time after starting infusion of study drug being taken as T0. T1 - After infusion is over T2 - Immediately after intubation T3 - 3 minutes after start of surgery T4 - 10 minutes after T5 - 30 minutes after T6 - 45 minutes after T7 - 60 minutes after T8 - 75 minutes after T9 - 90 minutes after T10 - Every 15 minutes after T11 - At end of surgery T12 - After extubation—

Countries

India

Contacts

Public ContactDr Niti Jayesh Desai

GMERS Medical College and Hospital, Gotri, Vadodara

anupchandnani29@gmail.com09925436505

Outcome results

None listed

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