Rectal TumorsDexNCT07385898
Effect of Dexmedetomidine on Lung Protection in Elderly Patients Undergoing Laparoscopic Surgery for Colorectal Cancer
A study testing Dexmedetomidine and Normal saline in people with Rectal Tumors and Tumor of Sigmoid Colon, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Rectal Tumors, Tumor of Sigmoid Colon, Lung Injury
- What is being tested?
- Dexmedetomidine and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 17 Apr 2023to 27 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- Patients with stage 4 or 5 chronic kidney disease
- Patients with hyperthyroidism, pheochromocytoma
- Patients with hearing, intellectual, communication, or cognitive impairments
- Patients who cannot cooperate with the study for any reason, or whom the investigator deems unsuitable for inclusion in this trial.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400000
About this study
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.
Read the detailed description
As the body ages, all organs and tissues gradually undergo aging. Research has found that aging becomes increasingly significant after age 60, with the main change in pulmonary tissue aging being atrophy and a substantial decrease in ventilatory function. In elderly patients undergoing surgery, mechanical ventilation during surgery further reduces lung compliance, leading to an increased risk of respiratory dysfunction and postoperative pulmonary complications, which severely affect patient safety and postoperative recovery. Furthermore, due to its advantages, such as minimal trauma, less postoperative pain, and faster wound recovery, laparoscopic surgery has gradually become an essential surgical approach. However, during surgery, pneumoperitoneum and head-down position can cause diaphragmatic elevation, increased thoracic pressure, increased airway pressure, decreased lung compliance, and further aggravation of respiratory dysfunction and postoperative pulmonary complications. Therefore, exploring effective measures to protect the lungs during the perioperative period has always been a critical research direction for anesthesiologists.
Dexmedetomidine is a highly selective α2-adrenergic receptor agonist that mainly functions as a sedative and hypnotic, often used as an adjuvant in anesthesia. In recent years, some studies have found that intravenous infusion of dexmedetomidine during single-lung ventilation in thoracic surgery can play a lung-protective role by reducing the inflammatory response, improving oxidative stress, improving respiratory mechanics, increasing oxygenation, and reducing postoperative pulmonary complications. In obese patients undergoing laparoscopic sleeve gastrectomy, continuous intravenous infusion of dexmedetomidine can improve respiratory mechanics and increase oxygenation. However, some studies have also found that constant intravenous infusion of dexmedetomidine during chest aortic surgery with low-temperature cardiac arrest does not improve perioperative respiratory mechanics and oxygenation. In addition, it is unclear whether dexmedetomidine also has a lung-protective effect in elderly patients undergoing laparoscopic surgery in the head-down position.
According to the latest data statistics, the incidence and mortality of colorectal cancer rank among the top five malignant tumors globally, making it one of the primary cancers that endanger life and health. Although colorectal cancer is showing a trend toward younger age, it is still predominantly seen in elderly patients. Laparoscopic surgery for tumor resection is the primary treatment method, and during the surgery, a head-down position is required to expose the surgical field fully. As the head-down angle is the same for rectal cancer and sigmoid colon cancer laparoscopic surgery, this project focuses on elderly patients undergoing laparoscopic rectal or sigmoid colon cancer surgery. It explores the lung-protective effect of continuous intravenous infusion of dexmedetomidine during surgery, providing guidance for anesthesia management in this patient population.
- Conditions
- Rectal Tumors, Tumor of Sigmoid Colon, Lung Injury, Surgery, Laparoscopic, Dexmedetomidine
- Being tested
- Dexmedetomidine, Normal saline
- Medical subject headings
- Rectal Neoplasms, Sigmoid Neoplasms, Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Dexmedetomidine Hydrochloride
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.
Normal salineOther
Also called Saline
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
oxygenation index
oxygenation index is the ratio of partial pressure of O2 in arterial blood to fraction of inspired oxygen, namely PaO2/FiO2 ratio.
Measured: 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
arterial carbon dioxide pressure assessed by arterial blood gas measurement.
Measured: 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
end-tidal carbon dioxide pressure assessed by arterial blood gas measurement.
Measured: 5 minutes after establishment of pneumoperitoneum and trendelenburg position (T1), 30 minutes after trendelenburg position (T2), 60 minutes after trendelenburg position (T3)
Pplat
plateau pressure (Pplat) is the end-inspiratory airway pressure and is measured just after airflow has ceased, which is displayed automatically on the anesthesia machine.
Measured: 5 minutes after establishment of pneumoperitoneum and trendelenburg position (T1), 30 minutes after trendelenburg position (T2), 60 minutes after trendelenburg position (T3)
Ppeak
peak airway pressure is the highest pressure measured during the respiratory cycle and is a function of both the resistance of the airways and the compliance of the respiratory system, which is displayed automatically on the anesthesia machine.
Measured: 5 minutes after establishment of pneumoperitoneum and trendelenburg position (T1), 30 minutes after trendelenburg position (T2), 60 minutes after trendelenburg position (T3)
lung compliance
lung compliance is defined as the change in lung volume for a unit change in transalveolar pressure, which is displayed automatically on the anesthesia machine.
Measured: 5 minutes after establishment of pneumoperitoneum and trendelenburg position (T1), 30 minutes after trendelenburg position (T2), 60 minutes after trendelenburg position (T3)
Vd/Vt
Vd/Vt represents dead space ventilation, which is the volume of ventilated air that does not participate in gas exchange. Vd/Vt = 1.14 × (PaCO2-EtCO2) / PaCO2-0.005.
Measured: 5 minutes after establishment of pneumoperitoneum and trendelenburg position (T1), 30 minutes after trendelenburg position (T2), 60 minutes after trendelenburg position (T3)
Qs/Qt
Qs/Qt is a measurement of pulmonary shunt. It describes the percentage of blood that reaches the left side of the heart without picking up oxygen. Qs/Qt = (CcO2 - CaO2) / (CcO2 - CvO2), where CcO2 = pulmonary end-capillary O2 content, same as alveolar O2 content, CaO2 = arterial O2 content, CvO2 = mixed venous O2 content.
Measured: 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)
PA-aO2
alveolar-arterial oxygen gradient measures the difference between the oxygen concentration in the alveoli and arterial system, which can be obtained from the arterial blood gas measurement.
Measured: 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)
SPO2
oxygen saturation refers to the amount of oxygen bound to hemoglobin in arterial blood.
Measured: When patients enter the operation room (T0), 5 minutes after trendelenburg position (T1), 30 (T2) and 60 (T3) minutes after trendelenburg position, when extubate the endotracheal tube (about 30 min postoperatively, T4), postoperative day 1-3
Blood pressure
Systolic blood pressure, diastolic blood pressure, mean arterial pressure
Measured: When patients enter the operation room (T0), 5 minutes after trendelenburg position (T1), 30 (T2) and 60 (T3) minutes after trendelenburg position, when extubate the endotracheal tube (about 30 min postoperatively, T4), postoperative day 1-3
HR
hear rate
Measured: When patients enter the operation room (T0), 5 minutes after trendelenburg position (T1), 30 (T2) and 60 (T3) minutes after trendelenburg position, when extubate the endotracheal tube (about 30 min postoperatively, T4), postoperative day 1-3
Lac
lactic acid in blood
Measured: When patients enter the operation room (T0), 5 (T1), 30 (T2) and 60 (T3) min after trendelenburg position, and when the tracheal tube was extubated (T4)
WBC
White blood cell counting in blood
Measured: before surgery, postoperative day 1
NEU
neutrophil counting in blood
Measured: before surgery, postoperative day 1
NEU(%)
percentage of neutrophil in blood
Measured: before surgery, postoperative day 1
TV
Tidal Volume
Measured: before surgery, postoperative day 1
MVV
minute ventilation volume
Measured: before surgery, postoperative day 1
RR
respiration rate
Measured: before surgery, postoperative day 1
Postoperative pulmonary complications
The incidence of postoperative pulmonary complications was assessed according to the Assess Respiratory Risk in Surgical Patients in Catalonia (ARISCAT) definition.
Measured: postoperative day 1, 2, and 3
The length of postoperative hospital stay
The days stayed in hosptial after surgery
Measured: From the first day after surgery until the date of discharged from the hospital, assessed up to 1 months.
Postoperative hospitalization costs
All fees cost postoperatively
Measured: From the first day after surgery until the date of discharged from the hospital, assessed up to 1 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start17 Apr 2023
- Primary completion3 Feb 2024
- Study completion27 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Rectal TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ling Dan, BD, Principal investigator, The Second Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07385898
- Sponsor's protocol ID
- Research NO. 64 for 2023
- Acronym
- Dex
- Status last verified
- Apr 2023
- First submitted
- 13 Dec 2023
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) will be available with the corresponding author when required.
Publications
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.
PubMed 35510198Jannu 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.
PubMed 32843795Kostroglou 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.
PubMed 34441805Lee 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.
PubMed 26716866Xia 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.
PubMed 26273134Hasanin 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.
PubMed 30103679Kim 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.
PubMed 34040043
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dexmedetomidine on Lung Protection in Elderly Patients Undergoing Laparoscopic Surgery for Colorectal Cancer
- ClinicalTrials.gov ID
- NCT07385898
- Acronym / sponsor ID
- Dex / Research NO. 64 for 2023
- Conditions
- Rectal Tumors, Tumor of Sigmoid Colon, Lung Injury, Surgery, Laparoscopic, Dexmedetomidine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- The Second Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- 3 Feb 2024 (actual)
- Study completion
- 27 Feb 2024 (actual)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
As the body ages, all organs and tissues gradually undergo aging. Research has found that aging becomes increasingly significant after age 60, with the main change in pulmonary tissue aging being atrophy and a substantial decrease in ventilatory function. In elderly patients undergoing surgery, mechanical ventilation during surgery further reduces lung compliance, leading to an increased risk of respiratory dysfunction and postoperative pulmonary complications, which severely affect patient safety and postoperative recovery. Furthermore, due to its advantages, such as minimal trauma, less postoperative pain, and faster wound recovery, laparoscopic surgery has gradually become an essential surgical approach. However, during surgery, pneumoperitoneum and head-down position can cause diaphragmatic elevation, increased thoracic pressure, increased airway pressure, decreased lung compliance, and further aggravation of respiratory dysfunction and postoperative pulmonary complications. Therefore, exploring effective measures to protect the lungs during the perioperative period has always been a critical research direction for anesthesiologists.
Dexmedetomidine is a highly selective α2-adrenergic receptor agonist that mainly functions as a sedative and hypnotic, often used as an adjuvant in anesthesia. In recent years, some studies have found that intravenous infusion of dexmedetomidine during single-lung ventilation in thoracic surgery can play a lung-protective role by reducing the inflammatory response, improving oxidative stress, improving respiratory mechanics, increasing oxygenation, and reducing postoperative pulmonary complications. In obese patients undergoing laparoscopic sleeve gastrectomy, continuous intravenous infusion of dexmedetomidine can improve respiratory mechanics and increase oxygenation. However, some studies have also found that constant intravenous infusion of dexmedetomidine during chest aortic surgery with low-temperature cardiac arrest does not improve perioperative respiratory mechanics and oxygenation. In addition, it is unclear whether dexmedetomidine also has a lung-protective effect in elderly patients undergoing laparoscopic surgery in the head-down position.
According to the latest data statistics, the incidence and mortality of colorectal cancer rank among the top five malignant tumors globally, making it one of the primary cancers that endanger life and health. Although colorectal cancer is showing a trend toward younger age, it is still predominantly seen in elderly patients. Laparoscopic surgery for tumor resection is the primary treatment method, and during the surgery, a head-down position is required to expose the surgical field fully. As the head-down angle is the same for rectal cancer and sigmoid colon cancer laparoscopic surgery, this project focuses on elderly patients undergoing laparoscopic rectal or sigmoid colon cancer surgery. It explores the lung-protective effect of continuous intravenous infusion of dexmedetomidine during surgery, providing guidance for anesthesia management in this patient population.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Experimental | Drug: DexmedetomidineAfter 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. |
| Control | Placebo comparator | Other: Normal salineAfter 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. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineAlso: Dexmedetomidine HydrochlorideAfter 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 |
| Normal salineAlso: SalineAfter 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 | Control |
Primary outcome
oxygenation index
Time frame: 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)
oxygenation index is the ratio of partial pressure of O2 in arterial blood to fraction of inspired oxygen, namely PaO2/FiO2 ratio.
21 secondary outcomes
PaCO2
Time frame: 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
Time frame: 5 minutes after establishment of pneumoperitoneum and trendelenburg position (T1), 30 minutes after trendelenburg position (T2), 60 minutes after trendelenburg position (T3)
Pplat
Time frame: 5 minutes after establishment of pneumoperitoneum and trendelenburg position (T1), 30 minutes after trendelenburg position (T2), 60 minutes after trendelenburg position (T3)
Ppeak
Time frame: 5 minutes after establishment of pneumoperitoneum and trendelenburg position (T1), 30 minutes after trendelenburg position (T2), 60 minutes after trendelenburg position (T3)
lung compliance
Time frame: 5 minutes after establishment of pneumoperitoneum and trendelenburg position (T1), 30 minutes after trendelenburg position (T2), 60 minutes after trendelenburg position (T3)
Vd/Vt
Time frame: 5 minutes after establishment of pneumoperitoneum and trendelenburg position (T1), 30 minutes after trendelenburg position (T2), 60 minutes after trendelenburg position (T3)
Qs/Qt
Time frame: 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)
PA-aO2
Time frame: 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)
SPO2
Time frame: When patients enter the operation room (T0), 5 minutes after trendelenburg position (T1), 30 (T2) and 60 (T3) minutes after trendelenburg position, when extubate the endotracheal tube (about 30 min postoperatively, T4), postoperative day 1-3
Blood pressure
Time frame: When patients enter the operation room (T0), 5 minutes after trendelenburg position (T1), 30 (T2) and 60 (T3) minutes after trendelenburg position, when extubate the endotracheal tube (about 30 min postoperatively, T4), postoperative day 1-3
HR
Time frame: When patients enter the operation room (T0), 5 minutes after trendelenburg position (T1), 30 (T2) and 60 (T3) minutes after trendelenburg position, when extubate the endotracheal tube (about 30 min postoperatively, T4), postoperative day 1-3
Lac
Time frame: When patients enter the operation room (T0), 5 (T1), 30 (T2) and 60 (T3) min after trendelenburg position, and when the tracheal tube was extubated (T4)
WBC
Time frame: before surgery, postoperative day 1
NEU
Time frame: before surgery, postoperative day 1
NEU(%)
Time frame: before surgery, postoperative day 1
TV
Time frame: before surgery, postoperative day 1
MVV
Time frame: before surgery, postoperative day 1
RR
Time frame: before surgery, postoperative day 1
Postoperative pulmonary complications
Time frame: postoperative day 1, 2, and 3
The length of postoperative hospital stay
Time frame: From the first day after surgery until the date of discharged from the hospital, assessed up to 1 months.
Postoperative hospitalization costs
Time frame: From the first day after surgery until the date of discharged from the hospital, assessed up to 1 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Background: PubMed 35510198Jiang 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.
- Background: PubMed 32843795Jannu 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.
- Background: PubMed 34441805Kostroglou 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.
- Background: PubMed 26716866Lee 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.
- Background: PubMed 26273134Xia 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.
- Background: PubMed 30103679Hasanin 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.
- Background: PubMed 34040043Kim 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.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) will be available with the corresponding author when required.
Related trials for Rectal Tumors
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ling Dan, BD principal investigator
The Second Affiliated Hospital of Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine and Normal saline in people with Rectal Tumors and Tumor of Sigmoid Colon, run by The Second Affiliated Hospital of Chongqing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oxygenation index (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07385898, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.