Hypothalamic NeoplasmsNCT03137615
The Cardiovascular Changes Associated With Septal Local Anaesthesia
An observational study of Hypothalamic Neoplasms and Pituitary Diseases, run by Sheffield Teaching Hospitals NHS Foundation Trust.
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? Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Hypothalamic Neoplasms, Pituitary Diseases, Anesthesia, Local
- What is being tested?
- Pituitary surgery and local anaesthetic injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing trans-sphenoidal resection of a pituitary tumour.
Who may be able to join
- Any adult patient undergoing trans-sphenoidal pituitary surgery.
Who cannot join
- Under 16 years of age, pregnancy, uncontrolled hypertension, allergy to any local anaesthetic, patient refusal or revision pituitary surgery.
About this study
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
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?
Read the 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.
- Being tested
- Pituitary surgery, local anaesthetic injection
- Medical subject headings
- Hypothalamic Neoplasms, Pituitary Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pituitary surgeryProcedure or surgery
Trans-sphenoidal resection of a pituitary gland lesion.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Pituitary surgery; Drug: local anaesthetic injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood pressure after administration of local anaesthesia
Changes in mean arterial pressure from baseline after infiltration of local anaesthetic.
Measured: 5 minutes
Secondary outcomes (3)
Change in heart rate after administration of local anaesthesia
Changes in mean arterial pressure from baseline after infiltration of local anaesthetic.
Measured: 5 minutes
Change in cardiac output after administration of local anaesthesia
Changes in cardiac output from baseline after infiltration of local anaesthetic.
Measured: 5 minutes
Change in systemic vascular resistance after administration of local anaesthesia
Changes in systemic vascular resistance from baseline after infiltration of local anaesthetic.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study startNov 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypothalamic NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthew D Wiles, FRCA FFICM, Study chair, Sheffield Teaching Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03137615
- Sponsor's protocol ID
- STH17059
- Status last verified
- Apr 2017
- First submitted
- 20 Nov 2015
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03137615
- Acronym / sponsor ID
- STH17059
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 3 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pituitary Surgery | – | Procedure: Pituitary surgery, Drug: local anaesthetic injectionPatients 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 |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing trans-sphenoidal resection of a pituitary tumour.
Key inclusion criteria (1 listed)
- Any adult patient undergoing trans-sphenoidal pituitary surgery.
Key exclusion criteria (1 listed)
- Under 16 years of age, pregnancy, uncontrolled hypertension, allergy to any local anaesthetic, patient refusal or revision pituitary surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pituitary surgeryTrans-sphenoidal resection of a pituitary gland lesion. | Procedure or surgery | Pituitary Surgery |
| local anaesthetic injectionThe 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). | Drug | Pituitary Surgery |
Primary outcome
Change in blood pressure after administration of local anaesthesia
Time frame: 5 minutes
Changes in mean arterial pressure from baseline after infiltration of local anaesthetic.
3 secondary outcomes
Change in heart rate after administration of local anaesthesia
Time frame: 5 minutes
Change in cardiac output after administration of local anaesthesia
Time frame: 5 minutes
Change in systemic vascular resistance after administration of local anaesthesia
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew D Wiles, FRCA FFICM study chair
Sheffield Teaching Hospitals NHS Foundation Trust
Questions about this trial
What is this clinical trial studying?
An observational study of Hypothalamic Neoplasms and Pituitary Diseases, run by Sheffield Teaching Hospitals NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blood pressure after administration of local anaesthesia (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2017.