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The Cardiovascular Changes Associated With Septal Local Anaesthesia

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03137615
Enrollment
15
Registered
2017-05-03
Start date
2014-11-30
Completion date
2015-06-30
Last updated
2017-05-03

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

Conditions

Hypothalamic Neoplasms, Pituitary Diseases, Anesthesia, Local

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.

Interventions

PROCEDUREPituitary surgery

Trans-sphenoidal resection of a pituitary gland lesion.

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).

Sponsors

Sheffield Teaching Hospitals NHS Foundation Trust
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in blood pressure after administration of local anaesthesia5 minutesChanges in mean arterial pressure from baseline after infiltration of local anaesthetic.

Secondary

MeasureTime frameDescription
Change in heart rate after administration of local anaesthesia5 minutesChanges in mean arterial pressure from baseline after infiltration of local anaesthetic.
Change in cardiac output after administration of local anaesthesia5 minutesChanges in cardiac output from baseline after infiltration of local anaesthetic.
Change in systemic vascular resistance after administration of local anaesthesia5 minutesChanges in systemic vascular resistance from baseline after infiltration of local anaesthetic.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026