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Phosphopofol Disodium versus Propofol on Hypotension and Electroencephalographic Characteristics after Anesthesia Induction in Adults Undergoing Laparoscopic Surgery: A Multicenter Randomized Controlled Trial

Phosphopofol Disodium versus Propofol on Hypotension and Electroencephalographic Characteristics after Anesthesia Induction in Adults Undergoing Laparoscopic Surgery: A Multicenter Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125586
Enrollment
Unknown
Registered
2026-05-28
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Post-induction hypotension

Interventions

Experimental Group:The fospropofol disodium group received fospropofol disodium injection (0.2 ml/kg) and 20% long chain fat emulsion placebo (0.4 ml/kg)
Control group:The control group received propofol medium/long chain fat emulsion (0.4 ml/kg) and normal saline placebo (0.2 ml/kg).

Sponsors

Qilu Hospital of Shandong University (Qingdao)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Adults aged 18 to 65 years, any gender; 2. American Society of Anesthesiologists (ASA) physical status classification I–III; 3.Scheduled to undergo elective laparoscopic surgery under general anesthesia (e.g., cholecystectomy, appendectomy, gynecologic laparoscopic surgery), with an expected surgical duration <= 2 hours; 4.Body mass index (BMI) 18.5–30.0 kg/m^2; 5.Voluntarily participate in the study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1: Known allergy to propofol, phosphopofol, soy, or eggs; 2: Severe cardiovascular diseases: Uncontrolled hypertension Unstable angina New York Heart Association (NYHA) functional class III–IV Severe arrhythmias; 3: Severe hepatic or renal dysfunction: Child-Pugh class B or C eGFR < 60 mL/min/1.73m^2; 4: Central nervous system disorders, history of psychiatric illness, or long-term use of sedatives, hypnotics, or antiepileptic drugs; 5: Predicted difficult airway; 6: History of chronic alcoholism or drug abuse; 7: Pregnancy or breastfeeding.

Design outcomes

Primary

MeasureTime frame
Post-induction hypotension;

Secondary

MeasureTime frame
Minimum BIS value;Time for BIS to decline from baseline to 50;Mean slope of BIS decline from baseline to the lowest value.;Proportion of patients with burst suppression (BIS 0) during induction.;Incidence of injection pain;Incidence of bradycardia (HR < 45 beats/min);I ncidence of postoperative nausea and vomiting;

Countries

China

Contacts

Public ContactJianjun Li

Qilu Hospital of Shandong University (Qingdao)

ljj9573@163.com+86 134 7557 5906

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026