Mean Arterial PressureNCT02974712
The Effects of Two Induction Means on Emergence After General Anesthesia
A study testing Fentanyl and Saline in people with Mean Arterial Pressure and Heart Rate, run by RenJi Hospital.
Trial summary
This study aims to investigate the effects of different methods of administration on emergence period after laryngeal mask anesthesia in elderly patients undergoing transurethral endoscopic operation Read more about this study
- Who is it for?
- Ages 65 to 79 years
- Conditions the study is for
- Mean Arterial Pressure, Heart Rate
- What is being tested?
- Fentanyl and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Mar 2017
- Phase
- Interventional
- 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 65 to 79 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- ASA level I or II,
- Aged from 65 to 79,
- With a duration of anesthesia <90 min.
Who cannot join
- Chronic obstructive pulmonary diseases (COPD),
- Severe heart disease,
- Difficult airway
- Liver and kidney dysfunction,
- Cerebrovascular disease,
- Bleeding volume >20 ml.
About this study
Official title: The Effects of Two Induction Means on Emergence After General Anesthesia for Elderly Patients Undergoing Transurethral Endoscopic Operation
This study aims to investigate the effects of different methods of administration on emergence period after laryngeal mask anesthesia in elderly patients undergoing transurethral endoscopic operation
- Conditions
- Mean Arterial Pressure, Heart Rate
- Being tested
- Fentanyl, Saline
- Keywords
- Arterial blood gases, MAP, HR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
SalineDrug
| Study group | Role | What they receive |
|---|---|---|
| Fentanyl | Experimental | After routine Induction, fentanyl was administrated. Receives: Drug: Fentanyl |
| Saline | Placebo comparator | After routine Induction, same volume saline was administrated. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean arterial pressure (MAP)
Measured: One hour after surgery
Secondary outcomes (1)
Lengths of stays in the Post anesthesia care unit(PACU)
Measured: One hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2016 (estimated)
- Study startDec 2016
- Primary completionMar 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mean Arterial PressureStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02974712
- Sponsor's protocol ID
- 20161114
- Status last verified
- Nov 2016
- First submitted
- 14 Nov 2016
- Last updated
- 28 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Two Induction Means on Emergence After General Anesthesia for Elderly Patients Undergoing Transurethral Endoscopic Operation
- ClinicalTrials.gov ID
- NCT02974712
- Acronym / sponsor ID
- 20161114
- Conditions
- Mean Arterial Pressure, Heart Rate
- Keywords
- Arterial blood gases, MAP, HR
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 28 Nov 2016 (estimated)
- 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.
This study aims to investigate the effects of different methods of administration on emergence period after laryngeal mask anesthesia in elderly patients undergoing transurethral endoscopic operation
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fentanyl | Experimental | Drug: FentanylAfter routine Induction, fentanyl was administrated. |
| Saline | Placebo comparator | Drug: SalineAfter routine Induction, same volume saline was administrated. |
Who may qualify
- Ages
- 65 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- ASA level I or II,
- Aged from 65 to 79,
- With a duration of anesthesia <90 min.
Key exclusion criteria (6 listed)
- Chronic obstructive pulmonary diseases (COPD),
- Severe heart disease,
- Difficult airway
- Liver and kidney dysfunction,
- Cerebrovascular disease,
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 |
|---|---|---|
| Fentanyl | Drug | Fentanyl |
| Saline | Drug | Saline |
Primary outcome
Mean arterial pressure (MAP)
Time frame: One hour after surgery
1 secondary outcome
Lengths of stays in the Post anesthesia care unit(PACU)
Time frame: One hour after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Fentanyl and Saline in people with Mean Arterial Pressure and Heart Rate, run by RenJi Hospital.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 28 Nov 2016. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Mean arterial pressure (MAP) (time frame: One hour after surgery). 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 28 Nov 2016.