The Anesthesia Effects of Dexmedetomidine Combined With Desflurane or Propofol in Lobectomy

NCT06207344 | Recruiting

• 1 other identifier: 2023.159
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Anesthesia Recovery Period; Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• Time to open eyes after anesthetics withdrawal

  The first 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.

Secondary Outcomes (14)

• Incidence of delirium

  From time of anesthetic withdrawal to the patient leaving the postanesthesia care unit, assessed up to 2 hour.

• Incidence of nausea and vomiting

  From time of anesthetic withdrawal to the patient leaving the postanesthesia care unit, assessed up to 2 hour.

• Pain level

  From time of anesthetic withdrawal to the patient leaving the postanesthesia care unit, assessed up to 2 hour.

• Incidences of other side effects

  From time of anesthetic withdrawal to the patient leaving the postanesthesia care unit, assessed up to 2 hour.

• Drugs and their dosage

  From time of anesthetic withdrawal to the patient leaving the postanesthesia care unit, assessed up to 2 hour.

Study Arms (2)

Dexmedetomidine and propofol

ACTIVE COMPARATOR

After anesthesia induction, dexmedetomidine was infused intravenously at 1 μg/kg within 15 min, then infused at 0.3 μg/kg/h until 30 min before the end of the operation. Propofol was infused intravenously at 4-12mg/kg/h to maintain the depth of anesthesia (patient state index between 25-50 monitored by Masimo SedLine).

Drug: Dexmedetomidine and propofol

Dexmedetomidine and desflurane

EXPERIMENTAL

After anesthesia induction, dexmedetomidine was infused intravenously at 1 μg/kg within 15 min, and 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 used to maintain the depth of anesthesia (patient state index between 25-50 monitored by Masimo SedLine).

Drug: Dexmedetomidine and desflurane

Interventions

Dexmedetomidine and propofol DRUG

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.

Also known as: Dexmedetomidine Hydrochloride injection and propofol injectable emulsion

Dexmedetomidine and propofol

Dexmedetomidine and desflurane DRUG

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.

Also known as: Dexmedetomidine Hydrochloride injection and Suprane

Dexmedetomidine and desflurane

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing elective thoracoscopic unilateral lobectomy.
• General anesthesia is required and the expected duration of one-lung ventilation is ≥ 1h.
• American Association of Anesthesiologists (ASA) physical condition classification I-III.
• Patients over 18 years old.
• Voluntary participation and ability to understand and sign the informed consent.

You may not qualify if:

• Obese patients (BMI\>28 kg/m2).
• patients with grade 3 hypertension (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg).
• Acute coronary syndrome, sinus bradycardia (heart rate \< 45 beats/min), II or III degree atrioventricular block, NYHA heart function classification III or IV.
• 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.
• Pulmonary artery pressure ≥60 mmHg.
• Patients with Child grade B or C of liver function.
• Patients with chronic kidney disease in stage 4 or 5.
• Patients with hyperthyroidism and pheochromocytoma.
• Patients who are expected to need mechanical ventilation after operation.
• People with hearing, intelligence, communication and cognitive impairment.
• 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.
• patients who are expected to be transferred to ICU after operation.

Sponsors & Collaborators

• The Second Affiliated Hospital of Chongqing Medical University: lead

Study Sites (2)

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400000, China

RECRUITING

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400000, China

RECRUITING

Related Publications (10)

• Campos JH, Feider A. Hypoxia During One-Lung Ventilation-A Review and Update. J Cardiothorac Vasc Anesth. 2018 Oct;32(5):2330-2338. doi: 10.1053/j.jvca.2017.12.026. Epub 2017 Dec 19. No abstract available.

  PMID: 29361458 BACKGROUND

• Bernasconi F, Piccioni F. One-lung ventilation for thoracic surgery: current perspectives. Tumori. 2017 Nov 23;103(6):495-503. doi: 10.5301/tj.5000638. Epub 2017 Jun 7.

  PMID: 28604996 BACKGROUND

• Karzai W, Haberstroh J, Priebe HJ. Effects of desflurane and propofol on arterial oxygenation during one-lung ventilation in the pig. Acta Anaesthesiol Scand. 1998 Jul;42(6):648-52. doi: 10.1111/j.1399-6576.1998.tb05296.x.

  PMID: 9689269 BACKGROUND

• Abe K, Shimizu T, Takashina M, Shiozaki H, Yoshiya I. The effects of propofol, isoflurane, and sevoflurane on oxygenation and shunt fraction during one-lung ventilation. Anesth Analg. 1998 Nov;87(5):1164-9. doi: 10.1097/00000539-199811000-00035.

  PMID: 9806702 BACKGROUND

• Cho YJ, Kim TK, Hong DM, Seo JH, Bahk JH, Jeon Y. Effect of desflurane-remifentanil vs. Propofol-remifentanil anesthesia on arterial oxygenation during one-lung ventilation for thoracoscopic surgery: a prospective randomized trial. BMC Anesthesiol. 2017 Jan 18;17(1):9. doi: 10.1186/s12871-017-0302-x.

  PMID: 28100177 BACKGROUND

• Kawanishi R, Kakuta N, Sakai Y, Hari Y, Sasaki H, Sekiguchi R, Tanaka K. Desflurane improves lung collapse more than propofol during one-lung ventilation and reduces operation time in lobectomy by video-assisted thoracic surgery: a randomized controlled trial. BMC Anesthesiol. 2022 Apr 29;22(1):125. doi: 10.1186/s12871-022-01669-7.

  PMID: 35488195 BACKGROUND

• Yuan JL, Kang K, Li B, Lu J, Miao MR, Kang X, Zhang JQ, Zhang W. The Effects of Sevoflurane vs. Propofol for Inflammatory Responses in Patients Undergoing Lung Resection: A Meta-Analysis of Randomized Controlled Trials. Front Surg. 2021 Jul 2;8:692734. doi: 10.3389/fsurg.2021.692734. eCollection 2021.

  PMID: 34277696 BACKGROUND

• Jannu V, Dhorigol MG. Effect of Intraoperative Dexmedetomidine on Postoperative Pain and Pulmonary Function Following Video-assisted Thoracoscopic Surgery. Anesth Essays Res. 2020 Jan-Mar;14(1):68-71. doi: 10.4103/aer.AER_9_20. Epub 2020 Mar 16.

  PMID: 32843795 BACKGROUND

• Jiang H, Kang Y, Ge C, Zhang Z, Xie Y. One-lung ventilation patients: Clinical context of administration of different doses of dexmedetomidine. J Med Biochem. 2022 Apr 8;41(2):230-237. doi: 10.5937/jomb0-33870.

  PMID: 35510198 BACKGROUND

• Xia R, Xu J, Yin H, Wu H, Xia Z, Zhou D, Xia ZY, Zhang L, Li H, Xiao X. Intravenous Infusion of Dexmedetomidine Combined Isoflurane Inhalation Reduces Oxidative Stress and Potentiates Hypoxia Pulmonary Vasoconstriction during One-Lung Ventilation in Patients. Mediators Inflamm. 2015;2015:238041. doi: 10.1155/2015/238041. Epub 2015 Jul 26.

  PMID: 26273134 BACKGROUND

MeSH Terms

Conditions

Postoperative Complications

Interventions

Dexmedetomidine; Propofol; Desflurane

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ethyl Ethers; Ethers; Methyl Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Officials

• Bing Chen

  The Second Affiliated Hospital of Chongqing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu Chen

CONTACT

8602362887913; cypgxhcj@tom.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: January 17, 2024
• Study Start: October 21, 2023
• Primary Completion: December 30, 2024
• Study Completion: June 30, 2025
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will become available when publish and keep it for 5 years.
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

CN (2)