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Double-blind randomized controlled study of esketamine general anesthesia combined with TAP in gynecological laparoscopic surgery

Double-blind randomized controlled study of esketamine general anesthesia combined with TAP in gynecological laparoscopic surgery

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000032358
Enrollment
Unknown
Registered
2020-04-26
Start date
2020-06-20
Completion date
Unknown
Last updated
2020-04-27

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

Conditions

gynecological laparoscopic surgery

Interventions

Control group:During induction, intravenous injection of saline. There is no esketamine in postoperative analgesia pump, and is replaced with an equal amount of normal saline. No difference in appeara
EK1:During induction, intravenous injection of 0.25 mg / ml esketamine. There is no esketamine in postoperative analgesia pump, and is replaced with an equal amount of normal saline.
EK2:During induction, intravenous injection of normal saline. There is 0.5mg/kg esketamine in postoperative analgesia pump.
EK3:During induction, intravenous injection of 0.25 mg / ml esketamine. There is 0.5mg/kg esketamine in postoperative analgesia pump.

Sponsors

The First Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1) The patient is between 18 and 60 years old; 2) Patients undergoing elective gynecological laparoscopic surgery; 3) ASA grade I or II; 4) 18.0 kg / m2 <= BMI<= 30.0 kg / m2.

Exclusion criteria

Exclusion criteria: 1) Patients who refuse to participate or those who should not participate in this trial; 2) Those allergic to esketamine, propofol or ropivacaine; 3) In the past, there were contraindications to the use of ketamine such as severe refractory hypertension, pulmonary heart disease, hyperthyroidism, epilepsy, increased intraocular pressure, increased intracranial pressure, or intracranial space occupying lesions, and a history of cerebrovascular accidents; 4) Patients with obstructive sleep apnea hypopnea syndrome or BMI> 30 kg / m2 or respiratory difficulties; 5) A history of alcoholism or taking psychotropic drugs or analgesic drugs within 24 hours before surgery; 6) Have a history of chronic pain; 7) During pregnancy or lactation; 8) Seizures; 9) Use drugs that affect the central nervous system; 10) Previous mental illnesses such as history of severe depression and mental illness.

Design outcomes

Primary

MeasureTime frame
Anesthesia recovery time;Dosage of opioids;Dosage of opioids;Hemodynamic indicators: such as blood pressure and heart rate;NRS score;

Secondary

MeasureTime frame
Postoperative analgesic consumption;Postoperative adverse reactions: such as nausea and vomiting, respiratory depression, phantom vision, etc.;

Countries

China

Contacts

Public ContactDan Cheng

The First Affiliated Hospital of Zhengzhou University

chengdan0607@163.com+86 037166271232

Outcome results

None listed

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