NCT03137615

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?

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2014

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2015

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

May 3, 2017

Completed
Last Updated

May 3, 2017

Status Verified

April 1, 2017

Enrollment Period

7 months

First QC Date

November 20, 2015

Last Update Submit

April 28, 2017

Conditions

Hypothalamic NeoplasmsPituitary DiseasesAnesthesia, Local

Outcome Measures

Primary Outcomes (1)

  • Change in blood pressure after administration of local anaesthesia

    Changes in mean arterial pressure from baseline after infiltration of local anaesthetic.

    5 minutes

Secondary Outcomes (3)

  • Change in heart rate after administration of local anaesthesia

    5 minutes

  • Change in cardiac output after administration of local anaesthesia

    5 minutes

  • Change in systemic vascular resistance after administration of local anaesthesia

    5 minutes

Study Arms (1)

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

Procedure: Pituitary surgeryDrug: local anaesthetic injection

Interventions

Pituitary surgeryPROCEDURE

Trans-sphenoidal resection of a pituitary gland lesion.

Pituitary Surgery
local anaesthetic injectionDRUG

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).

Pituitary Surgery

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing trans-sphenoidal resection of a pituitary tumour.

You may qualify if:

  • Any adult patient undergoing trans-sphenoidal pituitary surgery.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypothalamic NeoplasmsPituitary Diseases

Interventions

Anesthesia, Local

Condition Hierarchy (Ancestors)

Supratentorial NeoplasmsBrain NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypothalamic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and Analgesia

Study Officials

  • Matthew D Wiles, FRCA FFICM

    Sheffield Teaching Hospitals NHS Foundation Trust

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2015

First Posted

May 3, 2017

Study Start

November 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

May 3, 2017

Record last verified: 2017-04