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Clinical trial

Effect of Esketamine Combined With Butorphanol on Pain Management Following Video-assisted Lobectomy

ID
Name
2022-keyan-007
Description
Post-thoracotomy pain syndrome (PTPS) affects respiratory function, hindering sputum clearance and ventilation, and represents a significant complication of thoracic surgery. The analgesic effect of esketamine combined with butorphanol in PTPS is still unclear, so this study focused on this aspect.
Trial arms
Trial start
2022-03-01
Estimated PCD
2023-10-01
Trial end
2024-01-01
Status
Completed
Phase
Early phase I
Treatment
Esketamine
In the esketamine combined with butorphanol group (Group BK), patients received an intraoperative intravenous infusion of esketamine (0.3 mg/kg/h) followed by postoperative patient-controlled intravenous analgesia (PCIA) (esketamine 1.5 mg/kg + butorphanol 0.15 mg/kg + azasetron 20 mg).
Arms:
Group BK
Other names:
S-Ketamine, (S)-2-(o-chlorophenyl)-2-(methylamino)cyclohexanone, L-Ketamine, (-)-Ketamine
Butorphanol
In the butorphanol group (Group B), patients received an equivalent volume of normal saline intraoperatively and postoperatively received PCIA without esketamine.
Arms:
Group B, Group BK
Other names:
Butorphanol Tartrate, Moradol, Stadol, Torbugesic, Apo-Butorphanol, Dolorex
Size
223
Primary endpoint
Incidence of chronic pain
3 months post-surgery
Eligibility criteria
Inclusion Criteria: * Aged 20-70 years * Classified as American Society of Anesthesiologists I-III * Undergoing video-assisted lobectomy Exclusion Criteria: * Operative duration \< 1 hour * Significant comorbidities affecting vital organs such as liver, kidney, and heart * Severe infections * Immunodeficiency * Coagulation disorders * History of analgesic drug abuse * Severe dementia or communication barriers * Mental illnesses.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The enrolled participants were randomly allocated to either the butorphanol group (Group B) or the esketamine combined with butorphanol group (Group BK) at a 1:1 ratio.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 223, 'type': 'ACTUAL'}}
Updated at
2024-05-06

1 organization

2 products

4 indications

Organization
Second People's Hospital of Hefei City
Product
Esketamine
Indication
Esketamine
Indication
Pain
Indication
Post-thoracotomy Pain Syndrome
Indication
Thoracic Diseases
Product
Butorphanol