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The effect of different doses of esketamine on the incidence and quality of recovery in patients with cervical cancer: a double-blind, randomized controlled trial

The effect of different doses of esketamine on the incidence and quality of recovery in patients with cervical cancer: a double-blind, randomized controlled trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076916
Enrollment
Unknown
Registered
2023-10-24
Start date
2023-10-25
Completion date
Unknown
Last updated
2023-10-30

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

Conditions

Cervical cancer

Interventions

Saline group(Group N):Single intravenous injection of 10ml of saline was given 10min before skin cutting
Eesketamine 0.1 mg / kg group(Group A):Single intravenous injection of esketamine 0.1 mg / kg (diluted to 10ml) 10min before skin cutting
Eesketamine 0.2 mg / kg group(Group B):Single intravenous injection of esketamine 0.2 mg / kg (diluted to 10ml) 10min before skin cutting
Eesketamine 0.4 mg / kg group(Group C):Single intravenous injection of esketamine 0.4 mg / kg (diluted to 10ml) 10min before skin cutting

Sponsors

Affiliated Hospital of Xuzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
30 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age: 30~65 years old; 2. ASA grades I to II; 3. Cervical cancer stage III and below; 4.BMI 18~28 kg/m²; 5. Be able to complete the questionnaire independently and voluntarily sign the informed consent form to participate in this trial study.

Exclusion criteria

Exclusion criteria: 1.Severe cardiovascular and cerebrovascular diseases, kidney and liver diseases, or systemic inflammatory diseases; 2. Patients with hyperthyroidism and at risk of increased intracranial pressure; 3. Undercontrolled or untreated hypertension (arterial hypertension, resting systolic / diastolic blood pressure over 180 / 100mmHg); 4.The preoperative SDS score was greater than 53; patients with preoperative sleep disorders (Pittsburgh Scale); 5.Those with mental dysfunction before surgery, and those taking psychotropic drugs before surgery; 6.People with a history of psychotropic drugs, opioids, and alcohol dependence; 7.Allto the drug used in this trial; 8.Participate in other relevant clinical trials and refuse to participate.

Design outcomes

Primary

MeasureTime frame
Prevalence of depression within 7 days after surgery;

Secondary

MeasureTime frame
Self-rating Scale (SDS) at 1d, 3d, 5d and 7d;Recovery quality scale score at 1d, 3d, 5d and 7d (QoR-15);Sleep quality score on the 1d, 3d, 5d and 7d after operation;Postoperative drug withdrawal-extubation time;In-out PACU time;Time of first rescue analgesia after operation;The amount of remedial analgesic drugs at 1d, 3d, 5d and 7d;Length of postoperative hospitalization;Intraoperative remifentanil dosage;Intraoperative propofol dosage;Intraoperative mean arterial pressure;

Countries

China

Contacts

Public ContactYan Ming

Affiliated Hospital of Xuzhou Medical University

yiy3001@163.com+86 180 5226 8329

Outcome results

None listed

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