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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.

A comparative evaluation of preoperative nebulized dexmedetomidine, nebulized dexmedetomidine - lignocaine combination and nebulized saline on surgical field clarity and hemodynamic fluctuations during transnasal transsphenoidal pituitary tumour surgery and their ability to blunt intubation response-A RANDOMISED CONTROLLED TRIAL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/03/041234
Enrollment
75
Registered
2022-03-21
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Health Condition 1: E230- Hypopituitarism Health Condition 2: E240- Pituitary-dependent Cushings disease Health Condition 3: E220- Acromegaly and pituitary gigantism Health Condition 4: E221- Hyperprolactinemia Health Condition 5: E236- Other disorders of pituitary gland

Interventions

Intervention1: dexmedetomidine, lignocaine, normal saline: Arm 1 : nebulization of Dexmedetomidine at a dose of 1.5 µg/kg mixed with 2% lignocaine to a total volume of 5 ml. Arm 2 : nebulization of

Sponsors

Dr Ranganatha Praveen C S
Lead Sponsor
Dr Ajay Prasad Hrishi
Collaborator
Dr Manikandan Sethuraman
Collaborator

Eligibility

Inclusion criteria

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

Exclusion criteria: GCS Raised ICP(Intracranial pressure) Pregnant & nursing mothers, patients 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

Design outcomes

Primary

MeasureTime frame
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 surgeryTimepoint: 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

MeasureTime frame
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.Timepoint: 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. Post operative pain and throat discomfort-assessed within 24 hrs following surgery.—

Countries

India

Contacts

Public ContactRanganatha Praveen C S

SCTIMST,Trivandrum

drrpcs@gmail.com9855746254

Outcome results

None listed

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