## Protocol Section
### Identification Module
**NCT ID:** NCT06414018

**Acronym:** EOEDSAAIBT

**Brief Title:** Effect of Equivalent Dose Sufentanil and Afentanil in Bronchoscopic Treatment

**Official Title:** Effect Observation of Equivalent Dose Sufentanil and Afentanil Combined Laryngeal Mask for Complex Bronchoscopic Treatment

#### Organization Study ID Info
**ID:** EEDSA
#### Organization
**Class:** OTHER
**Full Name:** Tongji Hospital
### Status Module
#### Completion Date
**Date:** 2025-02-28

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-10

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-12-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-20

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-10
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Xinxiang Central Hospital

#### Lead Sponsor

**Class:** OTHER

**Name:** Tongji Hospital

#### Responsible Party

**Investigator Affiliation:** Tongji Hospital

**Investigator Full Name:** aijun xu

**Investigator Title:** clincal doctor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** The equivalent dose of sufentanil and afentanil combined with laryngeal mask was used for complex bronchoscopy to observe the intraoperative effect and the influence on the recovery of patients

**Detailed Description:** Afentanil is a powerful, fast-acting narcotic analgesic, which can effectively inhibit intubation reflex. Compared with sufentanil, it has a short half-life and is safer, and can be used as the first choice for short surgical analgesics. In this study, by comparing the use of equivalent dose sufentanil and afentanil combined with laryngeal mask for complex bronchoscopy, the intraoperative analgesic effect and the influence on the recovery of patients were observed, and a better anesthesia scheme was provided for tracheoscopy.

### Conditions Module

**Conditions:**

- Effect of Drug

**Keywords:**

- Afentanil

- sufentanil

- bronchoscopy

- Recovery time

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** TRIPLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 80

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The dose of sufentanil group is 0.2μg/kg

**Intervention Names:**

- Drug: Alfentanil

**Label:** Sufentanil group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** The dose of aifentanil group is 10μg/kg

**Intervention Names:**

- Drug: Alfentanil

**Label:** Alfentanil

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Alfentanil

- Sufentanil group

**Description:** alfentanil 10ug/kg is used for anesthesia induction

**Name:** Alfentanil

**Other Names:**

- sufentanil

**Type:** DRUG

### Outcomes Module

#### Other Outcomes

**Description:** Airway obstruction, hypoxemia, apnea, laryngeal spasm, bronchospasm, cough, postoperative nausea and vomiting, postoperative pain (VAS score), hypotension, bradycardia, dizziness

**Measure:** Postoperative adverse reaction

**Time Frame:** 1 day

#### Primary Outcomes

**Description:** the time from the end of surgery to awake of patient

**Measure:** Recovery time

**Time Frame:** 1day

#### Secondary Outcomes

**Description:** Anesthesia time, induction time, surgical time, awakening time and recovery time

**Measure:** Time records

**Time Frame:** 1 day

**Description:** The total amount of sedative and analgesic drugs used.

**Measure:** dose of drugs

**Time Frame:** 1 day

**Description:** Respiratory frequency\<8 times/min or SP02\<90%

**Measure:** Respiratory suppression incidence

**Time Frame:** 1 day

**Description:** Intraoperative blood pressure and heart rate changes: record the patient's intraoperative blood pressure, heart rate, and the use of related vasoactive drugs; Postoperative adverse reactions: such as hypertension, hypotension, tachycardia, gastrointestinal symptoms, postoperative restlessness, etc

**Measure:** Incidence of Treatment-Emergent Adverse Events

**Time Frame:** 1day

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Age 18-80,
* ASA I-III level;
* BMI 18.5\~23.9;

Exclusion Criteria:

* Patients with full stomach and high risk of reflux aspiration;
* Allergic to benzodiazepines, opioids, rocuronium bromide;
* Those who have taken sedative, analgesic or antidepressant drugs within 24 hours;
* Pregnant and lactating women;
* severe liver and kidney dysfunction;
* Patients with severe anemia and hypoproteinemia;
* Previous drug use history;
* Recently participated in other clinical studies;
* Patients who cannot cooperate with communication.

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** changmujun@hotmial.com

**Name:** mujun chang, doctor

**Phone:** 86-27-83663625

**Role:** CONTACT

**Contact 2:**

**Email:** ahdu@tjh.tjmu.edu.cn

**Name:** aihua du, doctor

**Phone:** 86-27-83663625

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Hubei

**Country:** China

**Facility:** Aijun Xu

**State:** Wuhan

**Zip:** 430000

#### Overall Officials

**Official 1:**

**Affiliation:** Tongji Hospital

**Name:** aijun xu, Dr

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** You can request it from the main researcher.

**IPD Sharing:** NO

## Derived Section

### Intervention Browse Module - Ancestors

- ID: D000000701

- Term: Analgesics, Opioid

- ID: D000009294

- Term: Narcotics

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000000700

- Term: Analgesics

- ID: D000018689

- Term: Sensory System Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000000759

- Term: Adjuvants, Anesthesia

- ID: D000018686

- Term: Anesthetics, Intravenous

- ID: D000018681

- Term: Anesthetics, General

- ID: D000000777

- Term: Anesthetics

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: AdjAn

- Name: Adjuvants, Anesthesia

- Abbrev: Analg

- Name: Analgesics

### Intervention Browse Module - Browse Leaves

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M19684

- Name: Sufentanil

- Relevance: HIGH

- As Found: Appointment

- ID: M18320

- Name: Alfentanil

- Relevance: HIGH

- As Found: Magnetic Resonance Spectroscopy

- ID: M117729

- Name: Dsuvia

- Relevance: LOW

- As Found: Unknown

- ID: M4032

- Name: Analgesics

- Relevance: LOW

- As Found: Unknown

- ID: M4033

- Name: Analgesics, Opioid

- Relevance: LOW

- As Found: Unknown

- ID: M12245

- Name: Narcotics

- Relevance: LOW

- As Found: Unknown

- ID: M4089

- Name: Adjuvants, Anesthesia

- Relevance: LOW

- As Found: Unknown

- ID: M20766

- Name: Anesthetics, Intravenous

- Relevance: LOW

- As Found: Unknown

- ID: M20761

- Name: Anesthetics, General

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000017409

- Term: Sufentanil

- ID: D000015760

- Term: Alfentanil

### Misc Info Module

- Version Holder: 2024-05-31
