Clinical Observation of Ciprofol for Anesthesia Induction

January 20, 2023 updated by: Xiumei Song

Clinical Observation of Ciprofol for Anesthesia Induction in the Elderly Undergoing Elective Non-cardiac Surgery

To evaluate the effect of ciprofol anesthesia Induction on hemodynamics in elderly patients undergoing elective noncardiac surgery，a prospective, randomized, controlled trial.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

90 elderly patients undergoing noncardiac surgery were randomly divided into propofol group and ciprofol group, who were given propofol 1 ~ 2mg/kg or ciprofol 0.2-0.5mg/kg during anesthesia induction respectively. Systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR) and BIS values at various time points during anesthesia induction were collected. At the same time, rates of injection pain, muscle fasciculation, arrhythmia, cough and perioperative hepatic and renal functions were compared between the two groups. The primary outcomes were the fluctuations in hemodynamic parameters during induction. The secondary outcome were adverse reactions, BIS values and changes of hepatic and renal functions during induction.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. ASA physical status Ⅰ-Ⅲ
  2. Age over 65 years;
  3. Body mass index (BMI) 20 ~ 30 kg/m2 ;
  4. Elective noncardiac surgery;

Exclusion Criteria:

  1. The patient or his/her family refused to participate in the clinical trial;
  2. Severe heart, lung, liver or kidney dysfunction;
  3. Expected difficult airway, requiring awake tracheal intubation;
  4. Those who are allergic to the drugs used in this study;
  5. Unsuccessful tracheal intubation twice;
  6. Patients with mental illness or impaired consciousness;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: propofol group
According to grouping，patients were premeditated with injection of Propofol 1-2mg / kg IV . If BIS is ≤ 60, Tracheal intubation was facilitated with cisatracurium 0.2mg/kg a IV and sufentanil 0.3 μ g / kg IV. if BIS is >60, propofol 0.5mg/kg was titrated intravenously, with an interval of more than 1min until the BIS is ≤ 60，and intubation was performed after cisatracurium and sufentanil injected .General anesthesia was maintained with Propofol and remifentanil.
Drug: Propofol
Propofol 1-2mg / kg was for anesthesia induction. Propofol is a hypnotic agent that is used as an induction agent and as a maintenance anaesthetic delivered by continuous i.v. infusion or intermittent i.v. bolus.
Experimental: ciprofol group
According to grouping，patients were premeditated with injection of ciprofol 0.2-0.5mg/kg IV. If BIS is ≤ 60, Tracheal intubation was facilitated with cisatracurium 0.2mg/kg a IV and sufentanil 0.3 μ g / kg IV. if BIS is >60, ciprofol 0.1mg/kg was titrated intravenously, with an interval of more than 1min until the BIS is ≤ 60，and intubation was performed after cisatracurium and sufentanil injected .General anesthesia was maintained with Propofol and remifentanil in both groups.
Drug: Ciprofol
Ciprofol 0.2～0.5mg/kg was for anesthesia induction. Ciprofol is an intravenous sedative-hypnotic and a short-acting GABAA receptor agonist. It activates GABAergic neurons by enhancing chloride ion influx. It is used for anesthetic induction and maintenance agents include rapid induction of general anesthesia, rapid return of consciousness, minimal residual effects on the central nervous system and less injection pain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemodynamic changes：Systolic blood pressure (SBP)
Time Frame: From the beginning of drug administration to 30 minutes after intubation
Systolic blood pressure (SBP) during anesthesia induction
From the beginning of drug administration to 30 minutes after intubation
Hemodynamic changes: Diastolic blood pressure(DBP)
Time Frame: From the beginning of drug administration to 30 minutes after intubation
Diastolic blood pressure(DBP) during anesthesia induction
From the beginning of drug administration to 30 minutes after intubation
Hemodynamic changes: Heart rate （HR ）
Time Frame: From the beginning of drug administration to 30 minutes after intubation
Heart rate （HR ）during anesthesia induction
From the beginning of drug administration to 30 minutes after intubation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adverse reactions: injection pain
Time Frame: anesthesia induction
injection pain from propofol or ciprofol intravenous injection
anesthesia induction
adverse reactions: muscle fasciculation
Time Frame: anesthesia induction
muscle fasciculation induced by propofol or ciprofol intravenous induction
anesthesia induction
adverse reactions：arrhythmia
Time Frame: anesthesia induction
arrhythmia induced by propofol or ciprofol intravenous induction
anesthesia induction
perioperative hepatic function: Aspartate Aminotransferase ( AST)
Time Frame: Before surgery , 1day after operation
level of Aspartate Aminotransferase ( AST)
Before surgery , 1day after operation
perioperative hepatic function: Alanine Aminotransferase ( ALT)
Time Frame: Before surgery , 1day after operation
level of Alanine Aminotransferase ( ALT)
Before surgery , 1day after operation
perioperative renal function: creatine
Time Frame: Before surgery , 1day after operation
level of creatine
Before surgery , 1day after operation
perioperative renal function:Blood Urea Nitrogen
Time Frame: Before surgery , 1day after operation
level of Blood Urea Nitrogen（BUN)
Before surgery , 1day after operation
Monitoring Depth of Anesthesia
Time Frame: anesthesia induction
BIS values
anesthesia induction

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiumei Song

Investigators

  • Study Chair: Xiumei Song, Doctor, Qian fo shan hospitial of shan dong province, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2023

Primary Completion (Anticipated)

September 30, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

November 29, 2022

First Submitted That Met QC Criteria

January 20, 2023

First Posted (Actual)

January 31, 2023

Study Record Updates

Last Update Posted (Actual)

January 31, 2023

Last Update Submitted That Met QC Criteria

January 20, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YXLL-KY-2022(060)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We plan to upload and share data with other researchers. Protecting patient privacy when sharing patient-level data from clinical trial

IPD Sharing Time Frame

study protocol and Informed Consent Form will available before 2024/1/1 Statistical Analysis Plan and Clinical Study Report will available before 2024/6/1

IPD Sharing Access Criteria

All registered researchers

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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