Clinical trial
The Anesthesia Effects of Dexmedetomidine Combined With Desflurane or Propofol in Lobectomy.
Name
2023.159
Description
In one-lung ventilation surgery, compared with dexmedetomidine combined with propofol, dexmedetomidine combined with desflurane may be beneficial to accelerate patients' recovery and reduce postoperative pulmonary complications and does not increase the incidences of delirium and postoperative nausea and vomiting.
Trial arms
Trial start
2023-10-21
Estimated PCD
2024-12-30
Trial end
2025-06-30
Status
Recruiting
Treatment
Dexmedetomidine and propofol
Group 1: After anesthesia induction, dexmedetomidine was infused at 1 μg/kg intravenously within 15 min, then infused at 0.3 μg/kg/h until 30 min before the end of the operation. Meantime, propofol was infused at 4-12mg/kg/h intravenously to maintain the depth of anesthesia.
Arms:
Dexmedetomidine and propofol
Other names:
Dexmedetomidine Hydrochloride injection and propofol injectable emulsion
Dexmedetomidine and desflurane
Group 2: After anesthesia induction, dexmedetomidine was infused at 1 μg/kg intravenously within 15 min, then infused at 0.3 μg/kg/h until 30 min before the end of the operation. At the same time, 2.5%-8.5% desflurane was inhaled to maintain the depth of anesthesia.
Arms:
Dexmedetomidine and desflurane
Other names:
Dexmedetomidine Hydrochloride injection and Suprane
Size
120
Primary endpoint
Time to open eyes after anesthetics withdrawal
From time of anesthetic withdrawal to the first time of the patient open his or her eyes, assessed up to 2 hour.
Eligibility criteria
Inclusion Criteria:
1. Patients undergoing elective thoracoscopic unilateral lobectomy.
2. General anesthesia is required and the expected duration of one-lung ventilation is ≥ 1h.
3. American Association of Anesthesiologists (ASA) physical condition classification I-III.
4. Patients over 18 years old.
5. Voluntary participation and ability to understand and sign the informed consent.
Exclusion Criteria:
1. Obese patients (BMI\>28 kg/m2).
2. patients with grade 3 hypertension (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg).
3. Acute coronary syndrome, sinus bradycardia (heart rate \< 45 beats/min), II or III degree atrioventricular block, NYHA heart function classification III or IV.
4. Patients with severe history of chronic obstructive pulmonary disease (GOLD grade III or IV of pulmonary function of chronic obstructive pulmonary disease), severe or uncontrolled bronchial asthma, pulmonary infection, bronchiectasis and thoracic deformity.
5. Pulmonary artery pressure ≥60 mmHg.
6. Patients with Child grade B or C of liver function.
7. Patients with chronic kidney disease in stage 4 or 5.
8. Patients with hyperthyroidism and pheochromocytoma.
9. Patients who are expected to need mechanical ventilation after operation.
10. People with hearing, intelligence, communication and cognitive impairment.
11. For any reason, it is impossible to cooperate with the study or the researcher thinks that it is not suitable to be included in this experiment.
12. patients who are expected to be transferred to ICU after operation.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}
Updated at
2024-03-13
1 organization
2 products
2 indications
Product
Dexmedetomidine + PropofolIndication
Post-anesthesia Recovery PeriodIndication
Postoperative ComplicationsProduct
Dexmedetomidine + Desflurane