NCT05401266

Brief Summary

We hypothesized that patients with mild hypercapnia during anesthetic emergence after TIVA had a shorter recovery time than patients with normal blood carbonate levels. We will select patients undergoing transurethral lithotripsy, who were expected to have mild postoperative pain, compare tracheal extubation time in patients with normal blood carbonic acid level and mild hypercapnia, to evaluate the effect of blood carbonic acid level during anesthetic emergence on recovery time from TIVA by. We also examined the changes of cerebral blood flow by TCD to investigate the possible mechanism of mild hypercapnia affecting the recovery time from TIVA.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
164

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 2, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

September 5, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

February 13, 2023

Status Verified

May 1, 2022

Enrollment Period

6 months

First QC Date

May 26, 2022

Last Update Submit

February 10, 2023

Conditions

Total Intravenous Anesthesia

Keywords

hypercapniarecovery timetotal intravenous anesthesia

Outcome Measures

Primary Outcomes (1)

  • Tracheal extubation time

    The time from propofol infusion stopped to Tracheal extubation

    1 year

Secondary Outcomes (5)

  • Time of anesthesia

    1 year

  • Total infusion of propofol and remifentanil

    1 year

  • Spontaneous respiratory recovery time

    1 year

  • Time of eyes or mouth opening

    1 year

  • Changes in cerebral blood flow examined by transcranial Doppler (TCD)

    1 year

Study Arms (2)

normal blood carbonic acid level

NO INTERVENTION

After propofol infusion was stopped, ventilation parameters were adjusted to maintain end-expiratory carbon dioxide (ETCO2) 35-40 mmHg until spontaneous respiration was restored.

mild hypercapnia

EXPERIMENTAL

After propofol infusion was stopped, ventilation parameters were adjusted to achieve and maintain ETCO2 50-55 mmHg until spontaneous respiration was restored.

Procedure: mild hypercapnia

Interventions

mild hypercapniaPROCEDURE

Ventilation parameters were adjusted to achieve and maintain ETCO2 50-55 mmHg until spontaneous respiration was restored

mild hypercapnia

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients aged 20-60 years, with American Society of Anesthesiology physical status 1 to 2, undergoing transurethral lithotripsy under TIVA with endotracheal intubation; voluntarily signed informed consent forms.

You may not qualify if:

  • Patients with mental, pulmonary, cardiac, endocrine, neuromuscular, liver and nervous system diseases or a history of such diseases; Lung CT showed atelectasis, pulmonary infection and pleural effusion. Patients taking sedatives or other drugs that might interfere with the study; Alcohol or drug dependence; Patients who have had a history of general anesthesia within the past month; Patients with body mass index (BMI) of 30 kg/m2 or above; Patients who are expected to be under anesthesia for less than 30 minutes; Patients with difficult airways.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

2ndAffiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Hypercapnia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Li Li Fang, PhD

    Study Official Affiliation

    STUDY DIRECTOR

Central Study Contacts

Lan Liu, Master

CONTACT

+86 13958033523zrll@zju.edu.cn

Li Na Yu, Professor

CONTACT

+86 13958033387zryulina@zju.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2022

First Posted

June 2, 2022

Study Start

September 5, 2022

Primary Completion

March 1, 2023

Study Completion

June 1, 2023

Last Updated

February 13, 2023

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)