The Effect of Mild Hypercapnia During Anesthetic Emergence on Recovery Time From TIVA

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.

Study Overview

• Status: Recruiting
• Conditions: Total Intravenous Anesthesia
• Intervention / Treatment: Procedure: mild hypercapnia

Detailed Description

At present, there is no effective intervention method for the recovery of general anesthesia, and the elimination of anesthetic agents, especially from the brain is a decisive factor in the emergence from general anesthesia. Many studies have reported the effect of hypercapnia on recovery time from volatile anesthetics. Hypercapnia can increase cardiac output and cerebral blood flow, increasing the ability to remove volatile anesthetics from the brain and shortening the recovery time from anesthesia.

Propofol is becoming the most common intravenous agent used for induction as well as maintenance of total intravenous anesthesia (TIVA). Its rapid elimination from the blood and brain is expected to shorten the recovery time from TIVA. Only a few clinical studies have investigated the relationship between hypercapnia and emergence time with propofol anesthesia. But those studies may have been influenced by postoperative pain, so the recovery time cannot reflect propofol metabolism alone. Moreover, intraoperative hypercapnia may increase the need for intraoperative anesthetic agents by increasing the clearance of agents from the brain.

As a non-invasive method, Transcranial Doppler ultrasonography（TCD）can be used to monitor blood flow changes in different parts of cerebral arterial circle(Willis circle）, and its safety and effectiveness in perioperative related fields have been proved.

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.

• Study Type: Interventional
• Enrollment (Anticipated): 164
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lan Liu, Master; Phone Number: +86 13958033523; Email: zrll@zju.edu.cn
• Study Contact Backup: Name: Li Na Yu, Professor; Phone Number: +86 13958033387; Email: zryulina@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • 2ndAffiliated Hospital, School of Medicine, Zhejiang University, China
      • Contact: Lan Liu, Master; Phone Number: +86 13958033523; Email: zrll@zju.edu.cn
      • Contact: Li Na Yu, PhD; Phone Number: +86 13958033387; Email: zryulina@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: normal blood carbonic acid level; After propofol infusion was stopped, ventilation parameters were adjusted to maintain end-expiratory carbon dioxide (ETCO2) 35-40 mmHg until spontaneous respiration was restored.
EXPERIMENTAL: mild hypercapnia; 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; Ventilation parameters were adjusted to achieve and maintain ETCO2 50-55 mmHg until spontaneous respiration was restored

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tracheal extubation time	The time from propofol infusion stopped to Tracheal extubation	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of anesthesia	Time from anesthesia induction to cessation of propofol infusion	1 year
Total infusion of propofol and remifentanil	Total infusion of propofol and remifentanil	1 year
Spontaneous respiratory recovery time	The time from the beginning of cessation of propofol infusion to the time when the patient begins to cough or when the ETCO2 waveform changes	1 year
Time of eyes or mouth opening	The time from the beginning of cessation of propofol infusion to the time when patients can open their eyes or mouth	1 year
Changes in cerebral blood flow examined by transcranial Doppler (TCD)	Examine at the following four time points: before anesthesia induction; 10min after operation; After adjustment of ETCO2 is completed in post-anaesthesia care unit(PACU); 20 min after tracheal extubation	1 year

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Study Director: Li Li Fang, PhD, Study Official Affiliation

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 5, 2022
• Primary Completion (ANTICIPATED): March 1, 2023
• Study Completion (ANTICIPATED): June 1, 2023

Study Registration Dates

• First Submitted: May 26, 2022
• First Submitted That Met QC Criteria: May 29, 2022
• First Posted (ACTUAL): June 2, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 13, 2023
• Last Update Submitted That Met QC Criteria: February 10, 2023
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: hypercapnia; total intravenous anesthesia; recovery time
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypercapnia
• Other Study ID Numbers: 2022-0389

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No