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The effect of preoperative anxiety on perioperative complications and its mechanism

The effect of preoperative anxiety on perioperative complications and its mechanism

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400079504
Enrollment
Unknown
Registered
2024-01-04
Start date
2023-03-03
Completion date
Unknown
Last updated
2024-01-08

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

Conditions

Preoperative anxiety

Interventions

Anxious ondansetron group (A group):Ondansetron
Anxious saline control group (B):Sterile saline
Non-anxious ondansetron group (C group):Ondansetron
Non-anxious saline control group (D group):Sterile saline
Parecoxib sodium group (group A):Parecoxib sodium
Flurbiprofen cilexetil (group B):Flurbiprofen ester
Saline control group (group C):Sterile saline
Prebiotic therapy group (Group A):Prebiotic
placebo control group (Group B):Placebo

Sponsors

The First People's Hospital of Yunnan Province
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Trial 1: (1) 350 patients who needed to undergo outpatient painless egg retrieval and hysteroscopy in the Department of Reproductive Medicine of the First People's Hospital of Yunnan Province. 120 patients underwent laparoscopic surgery; (2) Age 18~65 years old; (3) ASA grading I~II. Trial 2: (1) 60 patients who needed laparoscopic hysterectomy in the Department of Reproductive Medicine of the First People's Hospital of Yunnan Province; (2) Age 18~65 years old; (3) ASA grading I~II. Test 3: (1) Colorectal cancer confirmed by pathological examination; (2) Age 40 ~ 75 years old; (3) The patient is generally in good condition and has no serious cardiopulmonary dysfunction and metabolic diseases; (4) The patient has a known malignant tumor and the time is = 1 month, and the estimated survival time is =6 months; (5) No severe intestinal obstruction or intestinal perforation before surgery, and no radiotherapy or chemotherapy; (6) Cooperate with the completion of relevant investigations; (7) Patients and their families are aware of this study and sign the consent form.

Exclusion criteria

Exclusion criteria: Trial 1: (1) Those with a history of chemoradiotherapy within one week, using 5-HT receptor blocker antiemetics; (2) Heavy drinking, cognitive impairment, and mental disorders; (3) Those with limited intelligence level and inability to cooperate with the completion of the scale; (4) Patients with severe nausea and vomiting 24 hours before surgery; (5) History of cardiovascular and cerebrovascular diseases and diabetes mellitus in the past; abnormal coagulation function; peptic ulcers; Patients with severe abnormalities in liver and kidney function; (6) Allergy to any of the study drugs. Trial 2: (1) Heavy drinking, cognitive deficits, and mental disorders; (2) Those who have limited intelligence level and cannot cooperate with the completion of the scale; (3) History of cardiovascular and cerebrovascular diseases and diabetes mellitus in the past; abnormal coagulation function; peptic ulcers; Patients with severe abnormalities in liver and kidney function; (4) hypersensitivity to any of the study drugs; (5) History of opioids, analgesic and sedatives, and NSAIDS use 3 months before surgery; (6) Those with a history of chronic pain, central nervous system injury or surgery. Test 3: (1) with severe systemic disease or other types of malignant tumors; (2) With severe mental illness or cognitive impairment, the patient has recently suffered other major mental shocks; (3) The patient's operation time is more than 8 hours; (4) The amount of bleeding is greater than 500ml; (5) Severe intraoperative hypotension and cardiac arrest for rescue; (6) Those who have not completed follow-up blood collection/urine retention after surgery, or who have lost data for other reasons.

Design outcomes

Primary

MeasureTime frame
Postoperative nausea and vomiting;2-Arachidonic acid glyceryl;Arachidon ethanolamine;Plasma endotoxin;Interleukin-6;

Secondary

MeasureTime frame
Serotonin;

Countries

China

Contacts

Public ContactJin Hua

The First People's Hospital of Yunnan Province

jinhuakm@163.com+86 138 8866 8869

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 5, 2026