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Urinary SurgeryPhase 4NCT04443946

Different Anesthesia Maintain Protocol Effect the Outcome of the Patients

A Phase 4 study testing Propofol, 1% Sevoflurane and 1% Sevoflurane continue in people with Urinary Surgery and General Anesthesia, run by China International Neuroscience Institution at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This prospective open-label randomized study, patients were having elective urological surgery scheduled to last longer than 1 h under necessitating general anesthesia.Group-P: (Propofol group): 3 mg kg-1 min-1 propofol was pumped continuously after endotracheal intubation. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Urinary Surgery, General Anesthesia
What is being tested?
Propofol, 1% Sevoflurane and 1% Sevoflurane continue
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
25 Jun 2020to 5 Aug 2020
Phase
Phase 4
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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • the aged 18-65 yr,
  • ASA physical status I, II or III patients
  • having elective urological surgery
  • operation scheduled to last longer than 1 h
  • under necessitating general anesthesia

Who cannot join

  • refused to participate in the study;
  • were not able to communicate due to alterations in the level of consciousness, - a history of allergy to opioids
  • contraindications inhalational anaesthesia
  • family history of malignant hyperthermia
  • alcohol or drug abuse
  • received central nervous system-active drugs;
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  • body mass index ≥40 kg/m2
  • represent conditions liable to alter the pharmacokinetic and pharmacodynamic behaviors of the intravenous and inhalation anesthetics
  • previous head injury, neurologic or psychiatric disease
  • any disabling central nervous
  • cerebrovascular disease
  • current use of psychoactive or anti-convulsive medications
  • unstable angina
  • manifest congestive heart failure
  • airway management was expected to be difficult

Trial locations and contacts

1 site in 1 country.

China1 site

  • Xuanwu hospital

    Beijing, Beijing Municipality, 100053

Other trials in China

About this study

Official title: Different Anesthesia Maintain Protocol Effect the Outcome of the Patients Undergoing General Anesthesia for Urinary Surgery

This prospective open-label randomized study, patients were having elective urological surgery scheduled to last longer than 1 h under necessitating general anesthesia.Group-P: (Propofol group): 3 mg kg-1 min-1 propofol was pumped continuously after endotracheal intubation. Group-PAS: (Propofol and after 20 min adding Sevoflurane group): 3 mg kg-1 min-1 propofol were pumped continuously and add 1% end-tidal sevoflurane 20 minutes after endotracheal intubation. Group-PS: (Propofol and Sevoflurane group): 3 mg kg-1 min-1 propofol were continuously pumped after endotracheal intubation, and 1% sevoflurane was inhaled continuously at the same time. Group-S: (Sevoflurane group): 1% sevoflurane continued to maintain anesthesia after endotracheal intubation. Group-PSu: (Propofol and Sufentanil group): 3 mg kg-1 min-1 propofol, 0.01 μ g kg-1 min-1 sufentanil were pumped continuously at maintain phase

Read the detailed description

Group-P: (Propofol group): 3 mg kg-1 min-1 propofol was pumped continuously after endotracheal intubation. Group-PAS: (Propofol and after 20 min adding Sevoflurane group): 3 mg kg-1 min-1 propofol were pumped continuously and add 1% end-tidal sevoflurane 20 minutes after endotracheal intubation. Group-PS: (Propofol and Sevoflurane group): 3 mg kg-1 min-1 propofol were continuously pumped after endotracheal intubation, and 1% sevoflurane was inhaled continuously at the same time. Group-S: (Sevoflurane group): 1% sevoflurane continued to maintain anesthesia after endotracheal intubation. Group-PSu: (Propofol and Sufentanil group): 3 mg kg-1 min-1 propofol, 0.01 μ g kg-1 min-1 sufentanil were pumped continuously at maintain phase. Due to the ethical requirements of adequent analgesia, 0.3 μ g kg-1 min-1 remifentanil was continuously pumped as background input dose during anesthesia maintenance in all groups.

Being tested
Propofol, 1% Sevoflurane, 1% Sevoflurane continue, Sufentanil, 2% Sevoflurane

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PropofolDrug

    5 mg kg-1 h-1 propofol was pumped continuously after endotracheal intubation.

  • 1% SevofluraneDrug

    add 1% end-tidal sevoflurane 20 minutes after endotracheal intubation.

  • 1% Sevoflurane continueDrug

    Also called 1% Sevoflurane

    1% sevoflurane continued to maintain anesthesia after endotracheal intubation.

  • SufentanilDrug

    0.01 μ g kg-1 min-1 sufentanil were pumped continuously at maintain phase

  • 2% SevofluraneDrug

    Also called 2% Sevoflurane continue

    2% sevoflurane continued to maintain anesthesia after endotracheal intubation.

  • Propofol halfDrug

    Also called 2.5% Propofol

    2.5 mg kg-1 h-1 propofol was pumped continuously after endotracheal intubation.

Study groups in NCT04443946
Study groupRoleWhat they receive
Group-PActive comparatorGroup-P: (Propofol group): 5 mg kg-1 h-1 propofol was pumped continuously after endotracheal intubation.
Receives: Drug: Propofol
Group-PASExperimentalGroup-PAS: (Propofol and after 20 min adding Sevoflurane group): 2.5 mg kg-1 h-1 propofol were pumped continuously and add 1% end-tidal sevoflurane 20 minutes after endotracheal intubation.
Receives: Drug: 1% Sevoflurane; Drug: Propofol half
Group-PSExperimentalGroup-PS: (Propofol and Sevoflurane group): 2.5 mg kg-1 h-1 propofol were continuously pumped after endotracheal intubation, and 1% sevoflurane was inhaled continuously at the same time.
Receives: Drug: 1% Sevoflurane continue; Drug: Propofol half
Group-SExperimentalGroup-S: (Sevoflurane group): 2% sevoflurane continued to maintain anesthesia after endotracheal intubation.
Receives: Drug: 2% Sevoflurane
Group-PSuExperimentalGroup-PSu: (Propofol and Sufentanil group): 5 mg kg-1 h-1 propofol, 0.01 μ g kg-1 min-1 sufentanil were pumped continuously at maintain phase
Receives: Drug: Propofol; Drug: Sufentanil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Extubation Duration(ED)

    the extubation Duration (ED) was calculated as the time from the end of anesthesia to extubation of the LMA

    Measured: Up to 24 hours

Secondary outcomes (5)

  1. Length of PACU

    Length of PACU (Post-anesthesia care unit): From entering the PACU to discharge from the PACU

    Measured: Up to 24 hours

  2. qNOX

    Noceciption index,The qNOX of depth of analgesia also ranges from 99 to 0, and usually it is controlled to be within 40-60 during the operative period, with qNOX > 80 indicating an insufficient use of analgesic agents and qNOX < 10 indicating excessive analgesic effects.

    Measured: From entering the operation room until the discharge from the operation room, assessed up to 12 hours

  3. Bis

    Bispectral index,Bis 50-80 means appropriate Sedation depth

    Measured: From entering the operation room until the discharge from the operation room, assessed up to 12 hours

  4. Blood pressure

    measuring Systolic, Diastolic and Mean Blood Pressure

    Measured: From entering the operation room until the discharge from the operation room, assessed up to 12 hours

  5. The heart rate

    The heart rate

    Measured: From entering the operation room until the discharge from the operation room, assessed up to 12 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2020
  2. Study start25 Jun 2020
  3. Primary completion5 Aug 2020
  4. Study completion5 Aug 2020

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04443946
Sponsor's protocol ID
CINI-AD-20205-19
Status last verified
Jun 2020
First submitted
8 Jun 2020
Last updated
14 Oct 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Propofol, 1% Sevoflurane and 1% Sevoflurane continue in people with Urinary Surgery and General Anesthesia, run by China International Neuroscience Institution at 1 site in China.

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 5 inclusion and 15 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 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Extubation Duration(ED) (time frame: Up to 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04443946.

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 14 Oct 2020.

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