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Effects of Esketamine on Anesthetic Induction with Fospropofol Disodium: A Prospective, Multicenter, Randomized, Controlled Study

Effects of Esketamine on Anesthetic Induction with Fospropofol Disodium: A Prospective, Multicenter, Randomized, Controlled Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600116058
Enrollment
Unknown
Registered
2026-01-05
Start date
2026-01-07
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Thoracic Surgery

Interventions

Esketamine group(group L):Anesthesia induction was performed with esketamine 0.25 mg/kg and fospropofol disodium 20 mg/kg.
Normal saline group(group N):Anesthesia induction was performed with an equivalent volume of normal saline (to 0.25 mg/kg esketamine) plus fospropofol disodium 15 mg/kg.

Sponsors

Tai'an Central Hospital (Qingdao University Affiliated Tai'an Central Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) American Society of Anesthesiologists (ASA) physical status class I–III; (2) Aged 18–65 years, Gender inclusive; (3) Scheduled for elective thoracoscopic lobectomy or segmentectomy under general anesthesia with an expected operative time > 2 h; (4) Body-mass index (BMI) 18.0–30.0 kg/m²; (5) Voluntary written informed consent obtained.

Exclusion criteria

Exclusion criteria: (1) History of severe cardiac, cerebral, hepatic, renal, or pulmonary disease; (2) Obesity (BMI > 30.0 kg/m²) or underweight (BMI < 18.0 kg/m²); (3) Expected post-operative admission to the Intensive Care Unit (ICU) or return to ward with an endotracheal tube in situ; (4) Surgery within the preceding 2 months or participation in any other clinical drug trial within the past 2 months; (5) Severe disturbance of consciousness, cognitive dysfunction, or central nervous system disorders (e.g., psychiatric illness, Parkinson’s disease, Alzheimer’s disease); (6) Known or suspected hypersensitivity or contraindication to any component of the study drugs or protocol-specified medications (sufentanil citrate injection, remifentanil hydrochloride for injection, fospropofol disodium for injection, etc.).

Design outcomes

Primary

MeasureTime frame
Incidence of adverse body movement reactions during the induction period;

Secondary

MeasureTime frame
Time from induction to loss of consciousness, MOAA/S<=1;Incidence of post-induction hypotension;Incidence of injection pain during induction;Emergence time;Incidence of emergence agitation;

Countries

China

Contacts

Public ContactZaiqi Yang

Tai'an Central Hospital (Qingdao University Affiliated Tai'an Central Hospital, Taishan Medical Care Center)

yang_zaiqi@126.com+86 133 7538 8816

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026