Effect of Titrated Administration of Ciprofol on Perioperative Hypotension in Elderly Patients Undergoing Laparoscopic Abdominal Surgery: A Randomized Controlled Trial
NCT ID: NCT07328958
Last Updated: 2026-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
500 participants
INTERVENTIONAL
2026-01-07
2027-01-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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controled group
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. Depth of anesthesia will be continuously monitored; however, the monitoring results will remain blinded to the attending anesthesiologist.
No interventions assigned to this group
titrated group
In this group, anesthesia induction was performed with continuous infusion of ciprofol and remifentanil until loss of consciousness (OAA/S score = 1), followed by administration of 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.
titrated anesthesia
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.
Interventions
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titrated anesthesia
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.
Eligibility Criteria
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Inclusion Criteria
* American Society of Anesthesiologists (ASA) physical status I-III
* Requirement for invasive arterial blood pressure monitoring
Exclusion Criteria
* 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
65 Years
ALL
No
Sponsors
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Sixth Affiliated Hospital, Sun Yat-sen University
OTHER
Responsible Party
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SanQing Jin
professor
Locations
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Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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References
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Cannon JW. Hemorrhagic Shock. N Engl J Med. 2018 Jan 25;378(4):370-379. doi: 10.1056/NEJMra1705649. No abstract available.
Marchant A, Hartley MR. The action of pokeweed antiviral protein and ricin A-chain on mutants in the alpha-sarcin loop of Escherichia coli 23S ribosomal RNA. J Mol Biol. 1995 Dec 15;254(5):848-55. doi: 10.1006/jmbi.1995.0660.
Eisler I, Dare C, Russell GF, Szmukler G, le Grange D, Dodge E. Family and individual therapy in anorexia nervosa. A 5-year follow-up. Arch Gen Psychiatry. 1997 Nov;54(11):1025-30. doi: 10.1001/archpsyc.1997.01830230063008.
Gol'dberg VA. [The use of Difril in patients with chronic coronary insufficiency]. Klin Med (Mosk). 1968 Jun;46(6):100-3. No abstract available. Russian.
Bernasconi S, Vanelli M, Nori G, Siracusano MF, Marcellini C, Butturini A, De Luca F. Serum TSH, T4, T3, FT4, FT3, rT3, and TBG in youngsters with non-ketotic insulin-dependent diabetes mellitus. Horm Res. 1984;20(4):213-7. doi: 10.1159/000179999.
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.
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.
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.
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.
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.
Other Identifiers
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2025ZSLYEC-415
Identifier Type: -
Identifier Source: org_study_id
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