Determination of effect-site concentration of remifentanil for smooth emergence from combined epidural-general anesthesia in patients undergoing double lumen tube intubation surgery

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100054230

Enrollment

Unknown

Registered

2021-12-11

Start date

2021-12-11

Completion date

Unknown

Last updated

2022-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tracheal extubation

Interventions

Combined general-epidural anesthesia group:combined general-epidural anesthesia

Control group:General anesthesia

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients undergoing elective thoracoscopic lobectomy (two or three holes) under combined general-epidural anesthesia or general anesthesia, requiring one-lung ventilation with double-lumen endotracheal intubation; 2. Patients aged 18 to 65 years; 3. The American Society of Anesthesiologists (ASA) graded I-II; 4. Patients willing to sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with severe respiratory diseases, COPD, asthma, airway hyperresponsiveness, and upper respiratory tract infection within 2 weeks; 2. Patients with severe cardiovascular diseases, such as coronary heart disease, severe valvular disease, etc., and preoperative electrocardiogram indicating sinus bradycardia HR < 50 bpm; 3. Patients with contraindications for epidual block; 4. Patients with history of antitussive drugs, or long-term use of opioids due to chronic pain; 5. Patients with history of remifentanil allergy; 6. Pregnant or lactating women; 7. Patients who have participated in any drug clinical trial within 30 days before the start of the study; 8. Other conditions that the researchers think are not suitable for inclusion.

Design outcomes

Primary

Measure	Time frame
EC90;	—

Secondary

Measure	Time frame
EC95;EC99;Differences in mean arterial pressure (MAP), heart rate (HR), pulse oxygen saturation (SpO2), respiratory rate, BIS value, MAC between the two groups at each time point;The incidence of adverse events in the peri-awake period: bradycardia, hypotension, hypoxemia, laryngospasm, hoarseness;Ramsay pulse oxygen saturation (SpO2), respiratory rate, Aldrete sedation score, VAS (Visual Analogue Scale) score, PONV (post-operative nausea and vomiting), hoarseness or throat discomfort in PACU;	—

Measure

Time frame

EC95;EC99;Differences in mean arterial pressure (MAP), heart rate (HR), pulse oxygen saturation (SpO2), respiratory rate, BIS value, MAC between the two groups at each time point;The incidence of adverse events in the peri-awake period: bradycardia, hypotension, hypoxemia, laryngospasm, hoarseness;Ramsay pulse oxygen saturation (SpO2), respiratory rate, Aldrete sedation score, VAS (Visual Analogue Scale) score, PONV (post-operative nausea and vomiting), hoarseness or throat discomfort in PACU;

—

Countries

China

Contacts

Public ContactLiang Chao

Zhongshan Hospital Affiliated to Fudan University

Superwm226@aliyun.com+86 15921679955

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 10, 2026