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Effect of 5-HT3 Receptor Antagonists on Post-Induction Hypotension in Preoperatively Frail Elderly Patients: A Randomized Controlled Trial

Effect of 5-HT3 Receptor Antagonists on Post-Induction Hypotension in Preoperatively Frail Elderly Patients: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600118809
Enrollment
Unknown
Registered
2026-02-11
Start date
2026-02-12
Completion date
Unknown
Last updated
2026-02-16

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

Conditions

Post-Induction Hypotension in Preoperatively Frail Elderly Patients

Interventions

Trial Group (Induction Group):In the experimental group, a 5-mL syringe labeled with a white tag (containing a mixture of palonosetron hydrochloride 0.075 mg and normal saline) was administered before
Control Group (Conclusion Group):In the control group, a 5-mL syringe labeled with a white tag (containing normal saline) was administered before anesthesia induction. At the conclusion of surgery, fo

Sponsors

The Affiliated Hospital of Xuzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Age 60-85 years; 2. Elderly patients classified as ASA physical status ? to ?; 3. Scheduled for non-cardiac surgery under general anesthesia; 4. FFP score >= 3 points;

Exclusion criteria

Exclusion criteria: 1.History of severe hepatic impairment, defined as Child-Pugh Class C; 2.Prolonged QT interval on preoperative electrocardiogram (ECG); 3.Refusal to undergo surgery or to participate in this study; 4.Concomitant use of antidepressant or antipsychotic medications.

Design outcomes

Primary

MeasureTime frame
The incidence of post-induction hypotension, defined as the occurrence of a mean arterial pressure (MAP) less than 65 mmHg within 15 minutes after the initiation of general anesthesia induction.;

Secondary

MeasureTime frame
The area under the curve (AUC) for mean arterial pressure (MAP) below 65 mmHg within 15 minutes post-anesthesia induction.;The incidence of a greater than 20% reduction in mean arterial pressure (MAP) from baseline within 15 minutes after anesthesia induction.;The area under the curve (AUC) for mean arterial pressure (MAP) reduction exceeding 20% from baseline within 15 minutes after anesthesia induction.;The number and proportion of patients exhibiting a reduction in mean arterial pressure (MAP) exceeding 10% from baseline within 15 minutes after anesthesia induction.;The area under the curve (AUC) for mean arterial pressure (MAP) reduction exceeding 10% from baseline within 15 minutes after anesthesia induction.;The number and proportion of patients exhibiting a reduction in heart rate (HR) exceeding 10% from baseline within 15 minutes after anesthesia induction.;The area under the curve (AUC) for heart rate (HR) reduction exceeding 10% from baseline within 15 minutes after anesthesia induction.;Postoperative nausea and vomiting (PONV)-related scores assessed in the Post-Anesthesia Care Unit (PACU) and at 24 hours, 48 hours, and day 5 after surgery.;Dosage of anesthesia induction agents;Consumption of vasoactive agents within 15 minutes after anesthesia induction: doses of phenylephrine, ephedrine, atropine, urapidil, and esmolol.;Pain Visual Analog Scale (VAS) scores assessed in the Post-Anesthesia Care Unit (PACU) and at 24 hours (T24h), 48 hours (T48h), and postoperative day 5.;Quality of Recovery-15 (QoR-15) scores at 24 hours, 48 hours, and postoperative day 5.;Occurrence of delirium assessed in the Post-Anesthesia Care Unit (PACU) and at 24 hours (T24h), 48 hours (T48h), and postoperative day 5.;Sedation level assessed using the Ramsay Sedation Scale at 15 minutes after extubation.;Emergence time;Extubation time;Adverse events (including laryngospasm, oxygen desaturation, coughing, hemorrhage, pharyngeal edema, intraoperative awareness, etc.);Adverse reactio

Countries

China

Contacts

Public ContactZhang Yueying

The Affiliated Hospital of Xuzhou Medical University

zyy0218@126.com+86 180 5226 8602

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026