The Cardiovascular Changes Associated With Septal Local Anaesthesia

Anesthesia, Local Clinical Trial

Official title:

An Observational Study of the Cardiovascular Response to Infiltration of Local Anaesthetic Into the Nasal Septum in Patients Undergoing Trans-sphenoidal Resection of a Pituitary Lesion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03137615
• Other study ID #: STH17059
• Status: Completed
• Phase: N/A
• First received: November 20, 2015
• Last updated: April 28, 2017
• Start date: November 2014
• Est. completion date: June 2015

Study information

• Verified date: April 2017
• Source: Sheffield Teaching Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia, Local
• Hypothalamic Neoplasms
• Pituitary Diseases

Intervention

Procedure:
• Pituitary surgery
Trans-sphenoidal resection of a pituitary gland lesion.

Drug:
• local anaesthetic injection
The surgeon infiltrates the nasal septum with local anaesthesia as per usual practice. This consists of Moffet's solution and lidocaine with adrenaline (1:200,000).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in blood pressure after administration of local anaesthesia	Changes in mean arterial pressure from baseline after infiltration of local anaesthetic.	5 minutes
Secondary	Change in heart rate after administration of local anaesthesia	Changes in mean arterial pressure from baseline after infiltration of local anaesthetic.	5 minutes
Secondary	Change in cardiac output after administration of local anaesthesia	Changes in cardiac output from baseline after infiltration of local anaesthetic.	5 minutes
Secondary	Change in systemic vascular resistance after administration of local anaesthesia	Changes in systemic vascular resistance from baseline after infiltration of local anaesthetic.	5 minutes