Effects of Lidocaine Infusion on Hemodynamic Parameters in Endoscopic Transsphenoidal Surgery : a Prospective, Randomized, Double-blind

Phase 2

Recruiting

• Conditions: patients aged 18-65 years, ASA physical status 1-3 scheduled for elective endoscopic transsphenoidal surgery for pituitary tumor under general anesthesia in Ramathibodi hospital; lidocaine infusion, endoscopic transphenoidal surgery, pituitary tumor,

• Registration Number: TCTR20230911002
• Lead Sponsor: Faculty of Medicine Ramathibodi Hospital, Mahidol University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-11
• Study Completion: 2024-02-23
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Patients aged 18-65 years, ASA physical status 1-3 scheduled for elective endoscopic transsphenoidal surgery

Exclusion Criteria

1. Patient refusal
2. Allergy to Local anesthetic drug
3. Renal insufficiency (CKD stage IV-V)
4. Hepatic failure
5. History of cardiac arrhythmias or heart block
6. Revision Surgery
7. History of seizure or epilepsy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Heart Rate T1( baseline), T2 (intubation), T3 ( LA + ADR Packing), T4( Post ADR packing 2 min), T5 (Post ADR Packing 5 min), T6 (Post ADR packing 10 min), T7 (Bone work), T8 (Op. time 1 hr), T9 (End op), T10 min,Blood Pressure ( Mean arterial Pressure) T1( baseline), T2 (intubation), T3 ( LA + ADR Packing), T4( Post ADR packing 2 min), T5 (Post ADR Packing 5 min), T6 (Post ADR packing 10 min), T7 (Bone work), T8 (Op. time 1 hr), T9 (End op), T10 mmHg,Pulse pressure variation (PPV) T1( baseline), T2 (intubation), T3 ( LA + ADR Packing), T4( Post ADR packing 2 min), T5 (Post ADR Packing 5 min), T6 (Post ADR packing 10 min), T7 (Bone work), T8 (Op. time 1 hr), T9 (End op), T10 -

Secondary Outcome Measures

Name	Time	Method
Total fentanyl consumption end of surgery mcg,Total Lidocaine infusion dose end of surgery mg,Nicardipine dose end of surgery mg,Total Labetalol dose end of surgery mg,Total Ephedrine dose end of surgery mg,Total Levophed dose end of surgery mcg,Total atropine dose end of surgery mg,Postoperative pain score at PACU, 1 hr at PACU -,Sedation score at PACU, 1 hr at PACU Modified Ramsay scale score,PONV at PACU, 1 hr at PACU -