## Protocol Section
### Identification Module
**NCT ID:** NCT06413862

**Brief Title:** Ciprofol Versus Propofol in Patients Undergoing Painless Hysteroscopy

**Official Title:** Efficacy and Safety of Ciprofol Versus Propofol in Patients Undergoing Painless Hysteroscopy

#### Organization Study ID Info
**ID:** Ciprofol in hysteroscopy
#### Organization
**Class:** OTHER
**Full Name:** Baoding First Central Hospital
### Status Module
#### Completion Date
**Date:** 2024-07

**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:** 2024-06-09

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-10

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-07
**Study First Submit QC Date:** 2024-05-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Baoding First Central Hospital

#### Responsible Party

**Investigator Affiliation:** Baoding First Central Hospital

**Investigator Full Name:** Lei Zhu

**Investigator Title:** Chief Physician

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** Ciprofol exhibits comparable efficacy to that of propofol, and is associated with less injection pain rate, fewer adverse events, higher patient satisfaction, and more stable hemodynamics when used for general anesthesia during the painless hysteroscopy.

**Detailed Description:** In this study, we found that sedation success rate was 100% in both ciprofol group and propofol group during the painless hysteroscopy. The incidence rate of injection pain and the intensity of pain in the ciprofol group were significantly lower than the propofol group. Also, the ciprofol group had lower incidence rate and severity level of adverse events and higher patient satisfaction. In addition, SBP, DBP, and MAP values in propofol group were found to be significantly lower than those in ciprofol group at the time of cervical dilation and of consciousness recovery.

### Conditions Module

**Conditions:**

- Painless Hysteroscopy

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 188

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: Ciprofol

**Label:** Ciprofol group (ciprofol combined with alfentanil)

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Drug: Propofol

**Label:** Propofol group (propofol combined with alfentanil)

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Ciprofol group (ciprofol combined with alfentanil)

**Description:** The experimental group was slowly injected with ciprofol for 30 seconds (0.4mg/kg, Haisike Pharmaceutical Co., Ltd., Liaoning, China, batch number 20220911).

**Name:** Ciprofol

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Propofol group (propofol combined with alfentanil)

**Description:** The control group was slowly injected with propofol for 30 seconds (2mg/kg, Guorui Pharmaceutical Co., Ltd., Sichuan, China, batch number 22102914).

**Name:** Propofol

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** The injection pain was defined as the pain reported verbally by patients during the first injection of the investigational drugs (ciprofol or propofol). The Numerical Rating Scale (NRS) was used to evaluate the pain level. The anesthesiologist asks the patient during the first injection of the investigational drug (ciprofol or propofol), "Do you feel arm pain from the injection? Patients who answered "yes" was asked to describe the level of the pain (a score of 0 to 10 indicated "painless" to "unbearable pain"). The pain level was divided into painless (0 points), mild pain (1-3 points), and moderate to severe pain (4-10 points).

**Measure:** Injection pain

**Time Frame:** 24 hours within hysteroscopy

#### Secondary Outcomes

**Description:** No more than 5 supplementary doses within 15 minutes

**Measure:** Sedation success rate

**Time Frame:** 24 hours within hysteroscopy

**Description:** the absence of any alternative sedatives/anesthetic drugs after the initial administration of the investigational drugs

**Measure:** Anesthesia success rate

**Time Frame:** 24 hours within hysteroscopy

**Description:** the time from starting the administration of investigational drugs to the MOAA/S score ≤ 1

**Measure:** time for successful anesthesia induction

**Time Frame:** 24 hours within hysteroscopy

**Description:** the time from the last administration of investigational drugs to awaken

**Measure:** recovery time

**Time Frame:** 24 hours within hysteroscopy

**Description:** ephedrine, atropine

**Measure:** use of rescue drugs

**Time Frame:** 24 hours within hysteroscopy

**Description:** times of supplementing ciprofol or propofol

**Measure:** times of supplementing ciprofol or propofol

**Time Frame:** 24 hours within hysteroscopy

**Description:** nausea, vomiting, hypoxemia (blood oxygen saturation \< 90% and lasting \> 30 seconds), bradycardia (heart rate \< 55 beats/minute), hypotension (systolic blood pressure reduced by 20% compared to baseline), body movement (patient's unconscious limb movements) during the examination

**Measure:** adverse events

**Time Frame:** 24 hours within hysteroscopy

**Description:** graded based the National Cancer Institute Common Terminology Criteria for the Classification of Adverse Events (CTCAE) version 5.0, and divided into grade 1 (mild), grade 2 (moderate), grade 3 (severe or medically significant but not immediately life threatening), grade 4 (events with life-threatening consequences needing urgent intervention), grade 5 (death related to the adverse events)

**Measure:** severity level of adverse events

**Time Frame:** 24 hours within hysteroscopy

**Description:** using a 10-point scale, with 1 point indicating extreme dissatisfaction and 10 points indicating very satisfied

**Measure:** patient satisfaction

**Time Frame:** 24 hours within hysteroscopy

**Description:** The systolic blood pressure in mmHg, diastolic blood pressure in mmHg, mean arterial pressure in mmHg, blood oxygen saturation in %, and heart rate in bpm were recorded before anesthesia induction (T0), after anesthesia induction (T1), at cervical dilation (T2), and at consciousness recovery (T3)

**Measure:** comparison of vital signs before and after administration

**Time Frame:** 24 hours within hysteroscopy

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. age ≥ 18 years old;
2. undergoing hysteroscopy examination and requiring intravenous anesthesia;
3. American Society of Anesthesiologists (ASA) physical status I to II;
4. without communication difficulties, and able to cooperate with intervention implementation;
5. participating in this trial voluntarily, and signing an informed consent form;

Exclusion Criteria:

1. with contraindications for hysteroscopy examination (such as cervical stenosis, difficulty in cervical dilation, reproductive tract infections such as vaginitis and cervicitis) or allergies to the intended anesthetic drugs;
2. with severe cardiac insufficiency, liver and kidney dysfunction, and other major diseases;
3. with a history of uterine surgery within the past three months;
4. body temperature above 37.5 ℃ before the anesthesia;
5. long-term use of sedative or analgesic drugs.

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** zhuleizlzl@outlook.com

**Name:** Lei Zhu

**Phone:** +86-13785214850

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** the First Central Hospital of Baoding

**Name:** Lei Zhu

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Intervention Browse Module - Ancestors

- ID: D000006993

- Term: Hypnotics and Sedatives

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000045505

- Term: Physiological Effects of Drugs

- 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: Analg

- Name: Analgesics

### Intervention Browse Module - Browse Leaves

- ID: M18307

- Name: Propofol

- Relevance: HIGH

- As Found: Symptoms

- ID: M18320

- Name: Alfentanil

- Relevance: LOW

- As Found: Unknown

- ID: M10043

- Name: Hypnotics and Sedatives

- Relevance: LOW

- As Found: Unknown

- ID: M4107

- Name: Anesthetics

- 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: D000015742

- Term: Propofol

### Misc Info Module

- Version Holder: 2024-05-31
