Effect of Titrated Administration of Ciprofol on Perioperative Hypotension in Elderly Patients Undergoing Laparoscopic Abdominal Surgery: A Randomized Controlled Trial

NCT07328958 | Recruiting

• 1 other identifier: 2025ZSLYEC-415
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 2

Brief Summary

Elderly patients are frequently burdened with age-associated comorbidities and frailty, accompanied by physiological changes such as vascular stiffening, cardiac dysfunction, and impaired autonomic regulation. These factors not only increase the risk of adverse perioperative outcomes but also heighten sensitivity to anesthetic agents, making elderly patients particularly susceptible to anesthesia-related complications, especially hypotension. Consequently, optimizing anesthesia strategies for this high-risk population has become a critical goal in perioperative management. Titrated anesthesia, which individualizes anesthetic drug delivery based on patient response to achieve predefined endpoints, offers a potential approach to mitigating anesthetic risks. Ciprofol, a novel intravenous anesthetic, has been associated with less hemodynamic suppression compared with traditional agents; however, higher single doses may still predispose patients to hypotension. Remifentanil, an ultra-short-acting opioid, exerts significant cardiovascular depressive effects, further contributing to perioperative hypotension. It is hypothesized that titrated administration of anesthetic agents during both the induction and maintenance phases, compared with conventional fixed-dose protocols, may reduce the incidence of perioperative hypotension in elderly patients.

Conditions

Hypotension During Surgery

Keywords

elderly; general anesthesia; titrated; ciprofol

Outcome Measures

Primary Outcomes (1)

• Incidence of intraoperative hypotension.

  Hypotension is defined as at least one episode of mean arterial pressure (MAP) \<65 mmHg sustained for at least 1 minute.

  From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.

Secondary Outcomes (15)

• the time-weighted area under the curve (TWA) for MAP <65 mmHg during the anesthesia period

  From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.

• cumulative dose of norepinephrine and the proportion of patients requiring vasoactive support;

  From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.

• the time-weighted area under the curve (TWA) for MAP <0.8 baseline during the anesthesia period

  From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.

• Time to first hypotension

  From induction of general anesthesia to the end of surgery, assessed intraoperatively for up to 6 hours.

• CI trend during anesthesia

  From induction of general anesthesia to the beginning of surgery, assessed intraoperatively for up to 2 hours.

Study Arms (2)

controled group

NO INTERVENTION

Patients in this group will undergo anesthesia induction and maintenance with ciprofol and remifentanil. Induction will be performed with intravenous bolus administration of ciprofol at a dose of 0.4 mg/kg and remifentanil at a dose of 1.2μg/kg, followed by a neuromuscular blocker to facilitate tracheal intubation. During surgery, anesthetic doses will be adjusted at the discretion of the anesthesiologist, based on the patient's physiological parameters and surgical conditions. BIS monitoring is applied and the screen remains visible to the anesthesiologist. However, ciprofol dose adjustments are made according to routine clinical judgement without reference to a prespecified BIS target or structured titration rule.

titrated group

EXPERIMENTAL

In this group, anesthesia induction is performed with continuous infusion of ciprofol until loss of consciousness (OAA/S score = 1). Remifentanil 1.2 μg/kg is then administered, followed by a neuromuscular blocker to facilitate tracheal intubation. After intubation, anesthesia was maintained with ciprofol (0.4-3 mg/kg/h) and remifentanil (0.01-0.5 µg/kg/min) until the end of surgery. Depth of anesthesia was adjusted intraoperatively to maintain BIS at approximately 50.

Drug: titrated anesthesia

Interventions

titrated anesthesia DRUG

Anesthesia induction and maintenance will be performed with ciprofol and remifentanil. During the entire procedure, infusion rates will be adjusted according to a target BIS value of approximately 50, with anesthetic dosing continuously modified in response to BIS monitoring. The attending anesthesiologist will titrate anesthetic delivery based on BIS guidance rather than routine clinical judgment alone.

titrated group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥65 years, scheduled for elective laparoscopic abdominal surgery
• American Society of Anesthesiologists (ASA) physical status I-III
• Requirement for invasive arterial blood pressure monitoring

You may not qualify if:

• Participation in other clinical trials that may interfere with the intervention or outcomes of this study
• Severe hepatic or renal disease (GFR ≤30 mL/min/1.73 m², requirement for renal replacement therapy, or Child-Pugh class C liver function)
• Uncontrolled severe hypertension (preoperative SBP ≥180 mmHg or DBP ≥110 mmHg)
• Patients with severe mental disorders (such as schizophrenia), epilepsy, or Parkinson's disease, severe cognitive or intellectual impairment, severe visual or hearing impairments affecting assessment, or long-term alcohol abuse or use of sedative/analgesic medications;
• Known allergy to drugs used in this study
• Requirement for continuous vasopressor infusion before surgery, or intraoperative need for prolonged hemodynamic manipulation due to surgical factors
• Anticipated blood loss \>15% of estimated blood volume
• Expected surgical duration \<1 hours or \>6 hours
• Expected postoperative hospital stay \<72 hours

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (2)

Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

NOT YET RECRUITING

Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

RECRUITING

Related Publications (10)

• Cannon JW. Hemorrhagic Shock. N Engl J Med. 2018 Jan 25;378(4):370-379. doi: 10.1056/NEJMra1705649. No abstract available.

  PMID: 29365303 BACKGROUND

• Dell-Kuster S, Gomes NV, Gawria L, Aghlmandi S, Aduse-Poku M, Bissett I, Blanc C, Brandt C, Ten Broek RB, Bruppacher HR, Clancy C, Delrio P, Espin E, Galanos-Demiris K, Gecim IE, Ghaffari S, Gie O, Goebel B, Hahnloser D, Herbst F, Ioannidis O, Joller S, Kang S, Martin R, Mayr J, Meier S, Murugesan J, Nally D, Ozcelik M, Pace U, Passeri M, Rabanser S, Ranter B, Rega D, Ridgway PF, Rosman C, Schmid R, Schumacher P, Solis-Pena A, Villarino L, Vrochides D, Engel A, O'Grady G, Loveday B, Steiner LA, Van Goor H, Bucher HC, Clavien PA, Kirchhoff P, Rosenthal R. Prospective validation of classification of intraoperative adverse events (ClassIntra): international, multicentre cohort study. BMJ. 2020 Aug 25;370:m2917. doi: 10.1136/bmj.m2917.

  PMID: 32843333 BACKGROUND

• Lu Z, Zheng H, Chen Z, Xu S, Chen S, Mi W, Wang T, Chai X, Guo Q, Zhou H, Yu Y, Zheng X, Zhang J, Ai Y, Yu B, Bao H, Zheng H, Huang W, Wu A, Deng X, Ma H, Ma W, Tao L, Yang X, Zhang J, Liu T, Ma HP, Liang W, Wang X, Zhang Y, Du W, Ma T, Xie Y, Xie Y, Li N, Yang Y, Zheng T, Zhang C, Zhao Y, Dong R, Zhang C, Zhang G, Liu K, Wu Y, Fan X, Tan W, Li N, Dong H, Xiong L. Effect of Etomidate vs Propofol for Total Intravenous Anesthesia on Major Postoperative Complications in Older Patients: A Randomized Clinical Trial. JAMA Surg. 2022 Oct 1;157(10):888-895. doi: 10.1001/jamasurg.2022.3338.

  PMID: 35947398 BACKGROUND

• Futier E, Lefrant JY, Guinot PG, Godet T, Lorne E, Cuvillon P, Bertran S, Leone M, Pastene B, Piriou V, Molliex S, Albanese J, Julia JM, Tavernier B, Imhoff E, Bazin JE, Constantin JM, Pereira B, Jaber S; INPRESS Study Group. Effect of Individualized vs Standard Blood Pressure Management Strategies on Postoperative Organ Dysfunction Among High-Risk Patients Undergoing Major Surgery: A Randomized Clinical Trial. JAMA. 2017 Oct 10;318(14):1346-1357. doi: 10.1001/jama.2017.14172.

  PMID: 28973220 BACKGROUND

• Wildes TS, Mickle AM, Ben Abdallah A, Maybrier HR, Oberhaus J, Budelier TP, Kronzer A, McKinnon SL, Park D, Torres BA, Graetz TJ, Emmert DA, Palanca BJ, Goswami S, Jordan K, Lin N, Fritz BA, Stevens TW, Jacobsohn E, Schmitt EM, Inouye SK, Stark S, Lenze EJ, Avidan MS; ENGAGES Research Group. Effect of Electroencephalography-Guided Anesthetic Administration on Postoperative Delirium Among Older Adults Undergoing Major Surgery: The ENGAGES Randomized Clinical Trial. JAMA. 2019 Feb 5;321(5):473-483. doi: 10.1001/jama.2018.22005.

  PMID: 30721296 BACKGROUND

• Salmasi V, Maheshwari K, Yang D, Mascha EJ, Singh A, Sessler DI, Kurz A. Relationship between Intraoperative Hypotension, Defined by Either Reduction from Baseline or Absolute Thresholds, and Acute Kidney and Myocardial Injury after Noncardiac Surgery: A Retrospective Cohort Analysis. Anesthesiology. 2017 Jan;126(1):47-65. doi: 10.1097/ALN.0000000000001432.

  PMID: 27792044 BACKGROUND

• Maheshwari K, Turan A, Mao G, Yang D, Niazi AK, Agarwal D, Sessler DI, Kurz A. The association of hypotension during non-cardiac surgery, before and after skin incision, with postoperative acute kidney injury: a retrospective cohort analysis. Anaesthesia. 2018 Oct;73(10):1223-1228. doi: 10.1111/anae.14416. Epub 2018 Aug 24.

  PMID: 30144029 BACKGROUND

• D'Souza AW, Hissen SL, Manabe K, Takeda R, Washio T, Coombs GB, Sanchez B, Fu Q, Shoemaker JK. Age- and sex-related differences in sympathetic vascular transduction and neurohemodynamic balance in humans. Am J Physiol Heart Circ Physiol. 2023 Oct 1;325(4):H917-H932. doi: 10.1152/ajpheart.00301.2023. Epub 2023 Aug 18.

  PMID: 37594483 BACKGROUND

• Abdellatif M, Rainer PP, Sedej S, Kroemer G. Hallmarks of cardiovascular ageing. Nat Rev Cardiol. 2023 Nov;20(11):754-777. doi: 10.1038/s41569-023-00881-3. Epub 2023 May 16.

  PMID: 37193857 BACKGROUND

• Brauer D. [Evaluation of medical data using statistics software: the program packet ABSTAT]. Z Arztl Fortbild (Jena). 1988;82(18):905-8. No abstract available. German.

  PMID: 3213092 BACKGROUND

Central Study Contacts

Hong Bai, Doctoral student

CONTACT

+86 13480250519; bhong@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Data Analyst
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: January 9, 2026
• Study Start: January 16, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

CN (2)