Will steam inhalation of drug dexmedetomidine before surgery improve surgery conditions, control BP and heart rate during anesthesia breathing tube placement and surgery as compared to steam inhaled combination dexmedetomidine-lignocaine and saline in pituitary surgery through nose route.

Not yet recruiting

• Conditions: Hypopituitarism, (2) ICD-10 Condition: E240||Pituitary-dependent Cushings disease, (3) ICD-10 Condition: E220||Acromegaly and pituitary gigantism, (4) ICD-10 Condition: E221||Hyperprolactinemia, (5) ICD-10 Condition: E236||Other disorders of pituitary gland,

• Registration Number: CTRI/2022/03/041234
• Lead Sponsor: Dr Ranganatha Praveen C S

Brief Summary

In this prospective randomised control study we attempt to investigate the role of nebulized dexmedetomidine, combination of nebulized dexmedetomidine and lignocaine in improving the surgical field and blunting the hemodynamic response to local adrenaline nasal packing,intubation,achieveing optimal hemodynamic profile throughout the procedure and effect on postoperative pain and sore throat in transnasal transsphenoidal pituitary tumour surgery.It is based on the local vasoconstriction, sympatholytic and analgesic property of dexmedetomidine with no side effects of its intravenous route.Dexmedetomidine and its combination with lignocaine nebulization is safely reported to have been used for awake fibreoptic intubation.Also nebulized dexmedetomidine is found to blunt intubation response and also safely used for pediatric sedation(the dose which we intend to use is used safely in the mentioned areas).However nebulized dexmedetomidine or its combination with lignocaine is not used for transnasal pituitary surgeries till date while intravenous dexmedetomidine is used for the purpose but has side effects in intravenous dose(bradycardia,hypotension), which became the impetus of our study.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-03-19
• Study Start: 2022-03-28

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

ASA (American Society of Anaesthesiology) 1 and 2 Surgery for pituitary tumors via Transnasal trans sphenoidal surgery (TNTS) route Glasgow Coma Score(GCS) 15 Cushings and Acromegaly without cardiac abnormality.

Exclusion Criteria

• GCS <15 Raised ICP(Intracranial pressure) Pregnant & nursing mothers, patients < 18 years or more than 60 years.
• Pituitary apoplexy, Cushings and acromegaly with cardiac abnormality.
• ASA (American Society of Anaesthesiology) 3,4 and 5 Concomitant severe medical illness like decompensated heart failure, advanced liver disease, renal failure.
• History of allergy and previous nasal surgery.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the effects of nebulized dexmedetomidine-lignocaine combination, nebulized dex-medetomidine in saline and nebulized saline alone on intra operative surgical conditions and hemodynamic fluctuations in TNTS pituitary surgery	Surgical field assesment-Beginning of surgery, every 15 minutes from start of surgery till the tumour is reached. Hemodynamic assessment-Baseline,Beginning of surgery,every minute after packing soaked adrenaline gauze, at insertion of the endoscope and 3 minutes later, at the start of mucosal dissection and then every minute for 5 minutes, every 10 minutes for 1 hour, half- hourly for subsequent hours during surgery.

Secondary Outcome Measures

Name	Time	Method
To compare the effects of nebulized dexmedetomidine-lignocaine combination, nebulized dex-medetomidine in saline and nebulized saline alone on Hemodynamic responses to intubation, extubation, post operative pain, post operative throat discomfort due to throat pack and total Propofol/fentanyl/labetalol use.	Haemodynamics- Baseline, after nebulisation,intubation, immediately post intubation and every minute for next 5 minutes and every 2 minutes for next 5 minutes upto 10 minutes after intubation, at extubation and 5minutes after extubation.All these time points are done in the operation theatre.Total anesthetic agents used at different stages will be individually calculated at the end of the surgery.

Trial Locations

Locations (1)

Sree Chitra Tirunal Institute for Medical Sciences and Technology; 🇮🇳 Thiruvananthapuram, KERALA, India

Sree Chitra Tirunal Institute for Medical Sciences and Technology

🇮🇳Thiruvananthapuram, KERALA, India

Dr Ranganatha Praveen C S

Principal investigator

9855746254

drrpcs@gmail.com