Effect of Dexmedetomidine on Lung Protection in Elderly Patients Undergoing Laparoscopic Surgery for Colorectal Cancer

NCT07385898 | Completed

• 1 other identifier: Research NO. 64 for 2023
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The primary change in aging lung tissue among older people is atrophy, leading to a significant decline in ventilatory function. Intraoperative mechanical ventilation further decreases lung compliance and ventilatory function in elderly patients, making them more susceptible to respiratory dysfunction and postoperative pulmonary complications, which severely affects patient safety and postoperative recovery. Dexmedetomidine is a highly selective α2-adrenergic receptor agonist, and several studies have found that intravenous infusion of dexmedetomidine exerted lung protective effects during single-lung ventilation thoracic surgery. However, one study found that continuous intravenous dexmedetomidine infusion during low-temperature cardiac arrest aortic surgery did not improve perioperative respiratory mechanics and oxygenation. Therefore, this project aims to investigate the lung protective effects of continuous intravenous infusion of dexmedetomidine during laparoscopic surgery for elderly patients with rectal or sigmoid colon cancer.

Conditions

Rectal Tumors; Tumor of Sigmoid Colon; Lung Injury; Surgery, Laparoscopic; Dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• oxygenation index

  oxygenation index is the ratio of partial pressure of O2 in arterial blood to fraction of inspired oxygen, namely PaO2/FiO2 ratio.

  When patients enter the operation room (T0), 5 minutes after completion of pneumoperitoneum and trendelenburg position (T1), 30 (T2) and 60 (T3) minutes after trendelenburg position, when extubate the endotracheal tube (about 30 min postoperatively, T4)

Secondary Outcomes (21)

• PaCO2

  When patients enter the operation room (T0), 5 minutes after completion of pneumoperitoneum and trendelenburg position (T1), 30 (T2) and 60 (T3) minutes after trendelenburg position, when extubate the endotracheal tube (about 30 min postoperatively, T4)

• EtCO2

  5 minutes after establishment of pneumoperitoneum and trendelenburg position (T1), 30 minutes after trendelenburg position (T2), 60 minutes after trendelenburg position (T3)

• Pplat

  5 minutes after establishment of pneumoperitoneum and trendelenburg position (T1), 30 minutes after trendelenburg position (T2), 60 minutes after trendelenburg position (T3)

• Ppeak

  5 minutes after establishment of pneumoperitoneum and trendelenburg position (T1), 30 minutes after trendelenburg position (T2), 60 minutes after trendelenburg position (T3)

• lung compliance

  5 minutes after establishment of pneumoperitoneum and trendelenburg position (T1), 30 minutes after trendelenburg position (T2), 60 minutes after trendelenburg position (T3)

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

After anesthesia induction, intravenous infusion of dexmedetomidine at 1μg/kg was administered and completed within 20 minutes, followed by continuous infusion at 0.3μg/kg/h until 30 minutes prior to the end of surgery.

Drug: Dexmedetomidine

Control

PLACEBO COMPARATOR

After anesthesia induction, 0.25 ml/kg of normal saline was infused within 20 minutes, followed by a continuous infusion of 0.075 ml/kg/h until 30 minutes before the end of surgery.

Other: Normal saline

Interventions

Dexmedetomidine DRUG

After anesthesia induction, intravenous infusion of dexmedetomidine at 1μg/kg was administered and completed within 20 minutes, followed by continuous infusion at 0.3μg/kg/h until 30 minutes prior to the end of surgery.

Also known as: Dexmedetomidine Hydrochloride

Dexmedetomidine

Normal saline OTHER

After anesthesia induction, 0.25 ml/kg of normal saline was infused within 20 minutes, followed by a continuous infusion of 0.075 ml/kg/h until 30 minutes before the end of surgery.

Also known as: Saline

Control

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing elective laparoscopic surgery for rectal or sigmoid colon cancer.
• American Society of Anesthesiologists (ASA) physical status classification I-III.
• Age ≥60 years and \<85 years.
• Voluntary participation and ability to understand and sign the informed consent form.

You may not qualify if:

• Patients with obesity (BMI\>28 kg/m2)
• Grade 3 hypertensive patients (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg)
• Patients with acute coronary syndrome, sinus bradycardia (heart rate \<45 beats/minute), II or III degree atrioventricular block, or NYHA heart failure class III or IV
• Patients with a history of severe chronic obstructive pulmonary disease (COPD) (GOLD stage III or IV), severe or uncontrolled bronchial asthma, lung infections, bronchiectasis, thoracic deformities, and chest diseases (such as mediastinal tumors and thoracic tumors)
• Pulmonary artery pressure ≥ 60 mmHg
• Patients with Child-Pugh Class B or C liver function
• Patients with stage 4 or 5 chronic kidney disease
• Patients with hyperthyroidism, pheochromocytoma
• Patients with hearing, intellectual, communication, or cognitive impairments

Sponsors & Collaborators

• The Second Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400000, China

Location

Related Publications (7)

• 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

• 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

• Kostroglou A, Kapetanakis EI, Matsota P, Tomos P, Kostopanagiotou K, Tomos I, Siristatidis C, Papapanou M, Sidiropoulou T. Monitored Anesthesia Care with Dexmedetomidine Supplemented by Midazolam/Fentanyl versus Midazolam/Fentanyl Alone in Patients Undergoing Pleuroscopy: Effect on Oxygenation and Respiratory Function. J Clin Med. 2021 Aug 9;10(16):3510. doi: 10.3390/jcm10163510.

  PMID: 34441805 BACKGROUND

• Lee SH, Kim N, Lee CY, Ban MG, Oh YJ. Effects of dexmedetomidine on oxygenation and lung mechanics in patients with moderate chronic obstructive pulmonary disease undergoing lung cancer surgery: A randomised double-blinded trial. Eur J Anaesthesiol. 2016 Apr;33(4):275-82. doi: 10.1097/EJA.0000000000000405.

  PMID: 26716866 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

• Hasanin A, Taha K, Abdelhamid B, Abougabal A, Elsayad M, Refaie A, Amin S, Wahba S, Omar H, Kamel MM, Abdelwahab Y, Amin SM. Evaluation of the effects of dexmedetomidine infusion on oxygenation and lung mechanics in morbidly obese patients with restrictive lung disease. BMC Anesthesiol. 2018 Aug 14;18(1):104. doi: 10.1186/s12871-018-0572-y.

  PMID: 30103679 BACKGROUND

• Kim S, Park SJ, Nam SB, Song SW, Han Y, Ko S, Song Y. Pulmonary effects of dexmedetomidine infusion in thoracic aortic surgery under hypothermic circulatory arrest: a randomized placebo-controlled trial. Sci Rep. 2021 May 26;11(1):10975. doi: 10.1038/s41598-021-90210-w.

  PMID: 34040043 BACKGROUND

MeSH Terms

Conditions

Rectal Neoplasms; Sigmoid Neoplasms; Lung Injury

Interventions

Dexmedetomidine; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Colonic Neoplasms; Colonic Diseases; Sigmoid Diseases; Lung Diseases; Respiratory Tract Diseases; Thoracic Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• ling Dan, BD

  The Second Affiliated Hospital of Chongqing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Experimental Group: Intravenous infusion of 1 μg/kg dexmedetomidine was initiated after induction of anesthesia and completed within 20 minutes, followed by a continuous infusion of 0.3 μg/kg/h until 30 minutes prior to the end of surgery. Control Group: An equivalent volume of normal saline was administered via the same method. Data was recorded at the corresponding time points.

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: February 4, 2026
• Study Start: April 17, 2023
• Primary Completion: February 3, 2024
• Study Completion: February 27, 2024
• Last Updated: February 4, 2026

Record last verified: 2023-04

Data Sharing

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

Locations

CN (1)