The Cardiovascular Changes Associated With Septal Local Anaesthesia

Completed

• Conditions: Hypothalamic Neoplasms; Pituitary Diseases; Anesthesia, Local
• Interventions: Procedure: Pituitary surgery; Drug: local anaesthetic injection

• Registration Number: NCT03137615
• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

Brief Summary

The purpose of this study is to determine the effects on the heart of injecting local anaesthetic into the nose prior to surgery on the pituitary gland?

Detailed Description

People sometimes require surgery on their pituitary gland. This is a gland at the base of your brain which secretes hormones. At the Royal Hallamshire Hospital the investigators are currently conducting a study into the effects of local anaesthetic (a medicine which causes numbness) injection on patients undergoing this particular type of operation.

After patients are anaesthetised (asleep) but before surgery starts the surgeon injecst a local anaesthetic solution into the nose. This is routine practice and is done to provide pain relief afterwards and also to decrease the amount of bleeding during the operation to ensure that the surgeon has a good view.

The investigators have known for a long time that local anaesthetic affects the heart rate and blood pressure, however the investigators would like to describe exactly how, in much more detail.

Study Timeline

• Study Start: 2014-11
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Study First Submitted: 2015-11-20
• Status Verified: 2017-04
• Study First Submitted QC: 2017-04-28
• Last Update Submitted: 2017-04-28
• Study First Posted: 2017-05-03
• Last Update Posted: 2017-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Any adult patient undergoing trans-sphenoidal pituitary surgery.

Exclusion Criteria

• Under 16 years of age, pregnancy, uncontrolled hypertension, allergy to any local anaesthetic, patient refusal or revision pituitary surgery.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pituitary Surgery	Pituitary surgery	Patients having pituitary gland surgery Inclusion criteria - Any adult patient undergoing trans-sphenoidal pituitary surgery. Exclusion criteria - Under 16 years of age, pregnancy, uncontrolled hypertension, allergy to any local anaesthetic, patient refusal or revision pituitary surgery
Pituitary Surgery	local anaesthetic injection	Patients having pituitary gland surgery Inclusion criteria - Any adult patient undergoing trans-sphenoidal pituitary surgery. Exclusion criteria - Under 16 years of age, pregnancy, uncontrolled hypertension, allergy to any local anaesthetic, patient refusal or revision pituitary surgery

Primary Outcome Measures

Name	Time	Method
Change in blood pressure after administration of local anaesthesia	5 minutes	Changes in mean arterial pressure from baseline after infiltration of local anaesthetic.

Secondary Outcome Measures

Name	Time	Method
Change in heart rate after administration of local anaesthesia	5 minutes	Changes in mean arterial pressure from baseline after infiltration of local anaesthetic.
Change in cardiac output after administration of local anaesthesia	5 minutes	Changes in cardiac output from baseline after infiltration of local anaesthetic.
Change in systemic vascular resistance after administration of local anaesthesia	5 minutes	Changes in systemic vascular resistance from baseline after infiltration of local anaesthetic.