NCT07663695

Brief Summary

Post-induction hypotension (PIH) is a common and critical complication during general anesthesia, particularly in frail elderly patients whose physiological reserves are significantly diminished. PIH is strongly associated with adverse postoperative outcomes, including acute kidney injury (AKI) and myocardial injury. Propofol is the most widely used induction agent but frequently induces circulatory depression. Ciprofol, a novel anesthetic agent developed by optimizing the molecular structure of propofol, has demonstrated improved hemodynamic stability and fewer adverse effects in general populations. However, its specific impact on frail elderly patients remains unestablished. The primary purpose of this single-center, randomized, double-blind, controlled trial is to compare the effects of propofol and ciprofol during anesthesia induction on the incidence of PIH in frail elderly patients undergoing major abdominal surgery. The investigator's hypothesis is that ciprofol will significantly lower the incidence of PIH compared to propofol. Additionally, the study will evaluate secondary clinical outcomes, such as postoperative AKI, postoperative cardiac complications, and the overall quality of recovery, to provide an evidence-based clinical guide for selecting optimal induction agents for this vulnerable patient population.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress17%
Jun 2026Jan 2027

First Submitted

Initial submission to the registry

June 17, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 23, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

June 25, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Last Updated

June 23, 2026

Status Verified

June 1, 2026

Enrollment Period

6 months

First QC Date

June 17, 2026

Last Update Submit

June 17, 2026

Conditions

Hypotension

Keywords

PropofolCiprofolAnesthesia InductionFrail Elderly

Outcome Measures

Primary Outcomes (1)

  • Incidence of post-induction hypotension (PIH)

    Post-induction hypotension (PIH) is defined as a mean arterial pressure (MAP) \< 65 mmHg lasting for more than 1 minute.

    From the initiation of general anesthesia drug administration until 10 minutes after endotracheal intubation.

Study Arms (2)

Ciprofol

EXPERIMENTAL

Frail elderly patients undergoing major abdominal surgery who receive ciprofol for general anesthesia induction, combined with midazolam, sufentanil, and rocuronium.

Drug: Ciprofol

Propofol Group

ACTIVE COMPARATOR

Frail elderly patients undergoing major abdominal surgery who receive propofol for general anesthesia induction, combined with midazolam, sufentanil, and rocuronium.

Drug: Propofol

Interventions

CiprofolDRUG

An innovative 2,6-disubstituted phenol derivative used for general anesthesia induction.

Ciprofol
PropofolDRUG

An alkylphenol derivative and standard intravenous anesthetic agent used for general anesthesia induction.

Propofol Group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled to undergo major abdominal surgery under general anesthesia.
  • Frailty score \>= 3\[cite: 2\].
  • Age \>= 60 years\[cite: 2\].
  • American Society of Anesthesiologists (ASA) physical status class \>= II\[cite: 2\].
  • Planned invasive blood pressure monitoring\[cite: 2\].

You may not qualify if:

  • Severe cardiac arrhythmia\[cite: 2\].
  • Severe valvular heart disease\[cite: 2\].
  • Poorly controlled hypertension with medication (systolic blood pressure \>= 180 mmHg and/or diastolic blood pressure \>= 110 mmHg)\[cite: 2\].
  • Pre-existing preoperative hypotension (mean arterial pressure \< 65 mmHg)\[cite: 2\].
  • Preoperative renal dysfunction (serum creatinine greater than the upper limit of normal)\[cite: 2\].

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750000, China

Location

MeSH Terms

Conditions

Hypotension

Interventions

(2-(1R)-1-cyclopropyl)ethyl-6-isopropyl-phenolPropofol

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Central Study Contacts

Hongmei Ma

CONTACT

+86 1390971326013909713260@138.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2026

First Posted

June 23, 2026

Study Start

June 25, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

January 31, 2027

Last Updated

June 23, 2026

Record last verified: 2026-06

Locations

CN(1)