The Effect of Dexmedetomidine on Oxygen During One Lung Ventilation in Pediatric Surgery.

NCT04932746 | Completed

• 1 other identifier: UDMS-Anesth-01-2021
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

The children who will undergo OLV (one lung ventilation) through general anesthesia will be divided into two groups: The first will be intravenous infusion of dexmedetomidine at 0.4 mcg / kg / hour, and the second will be intravenous infusion of normal saline. We will take three samples of arterial blood gas (ABG) during the surgery at certain times. We record the hemodynamic values, PaO2, and calculate the value of the shunt Qs / Qt.

Conditions

One Lung Ventilation OLV; Esophageal Atresia; Hydrocystoma; Pneumonectomy; Pleura; Abscess

Keywords

Dexmedetomidine; One lung ventilation OLV; Hypoxic pulmonary vasoconstriction HPV; Pulmonary shunt fraction Qs / Qt

Outcome Measures

Primary Outcomes (2)

• Evaluation of change in PaO2 during surgery

  PaO2 : The partial pressure of oxygen The partial pressure of oxygen, also known as PaO2, is a measurement of oxygen pressure in arterial blood. It reflects how well oxygen is able to move from the lungs to the blood

  Three measurements will be taken over three times: T1: 10 min after induction of anesthesia and before OLV, T2: 10 min after lung isolation and OLV single lung ventilation, and T3: 60 min after OLV procedure.

• Evaluation of change in Qs/Qt during surgery. Qs/Qt: is a measurement of pulmonary shunt. Qs: blood flow through the shunt, Qt : total blood flow.

  It describes the percentage of blood that reaches the left side of the heart without picking up oxygen. The pulmonary shunt fraction (Qs/Qt) is calculated from the equation Qs/Qt = (CcO2 - CaO2)/(CcO2 - CvO2) Parameters we need to the equation: 1. Measurement of arterial blood gases ABG from arteries (radial or aorta) and the values it provides: 1. PaO2: partial pressure of arterial oxygen 2. SaO2: the degree of oxygen saturation of arterial hemoglobin 3. Hb: hemoglobin 2. Measurement of ABG from the pulmonary artery or from the right atrium via central catheter 1. PvO2: partial pressure of venous oxygen 2. SvO2: the degree of oxygen saturation of venous hemoglobin 3. Hb: hemoglobin 3. The following values 1. PB = (759 \~ 760) atmospheric pressure 2. PH2O = 47 water vapor pressure at a body temperature of 37 3. RQ = 0.8: RER = respiratory exchange rate when anesthetized 4. FiO2 The Fraction of Inspired Oxygen

  Three measurements will be taken over three times: T1: 10 min after induction of anesthesia and before OLV, T2: 10 min after lung isolation and OLV single lung ventilation, and T3: 60 min after OLV procedure.

Secondary Outcomes (3)

• Evaluation of change in CaO2 during surgery

  Three measurements will be taken over three times: T1: 10 min after induction of anesthesia and before OLV, T2: 10 min after lung isolation and OLV single lung ventilation, and T3: 60 min after OLV procedure.

• Evaluation of change in CvO2 during surgery

  Three measurements will be taken over three times: T1: 10 min after induction of anesthesia and before OLV, T2: 10 min after lung isolation and OLV single lung ventilation, and T3: 60 min after OLV procedure.

• Evaluation of change in Cc'O2 during surgery

  Three measurements will be taken over three times: T1: 10 min after induction of anesthesia and before OLV, T2: 10 min after lung isolation and OLV single lung ventilation, and T3: 60 min after OLV procedure.

Study Arms (2)

The dexmedetomidine group:

EXPERIMENTAL

An initial dose of 1 mcg / kg 1 dexmedetomidine will be given 10 minutes after the start of anesthesia infusion within 10 minutes, after which the dexmedetomidine infusion is maintained at a dose of 0.4 mcg / kg / hour. The injection will be stopped before the skin is closed.

Drug: Dexmedetomidine

The Placebo group (the control group):

EXPERIMENTAL

After the same anesthesia, the same amount of Saline solution will be administered, instead of dexmedetomidine, with the same protocol.

Drug: Placebo

Interventions

Dexmedetomidine DRUG

Infusion syringes are supplied with a concentration of 0.25 mcg / mL (dexmedetomidine or placebo) either 80 mcg / 20 mL, 200 mcg / 50 mL, or 400 mcg / 100 mL. It begins with infusion of 4 ml within 10 minutes and then continues infusion, depending on the child's weight, at 1.6 ml / kg / h. All injections will be prepared randomly by a doctor who did not participate in the study, and then placed in unmarked infusion pumps, given to an anesthesiologist (more than 10 years experience in pediatric anesthesia) without knowledge of the infusion content. The randomization process is carried out via sealed envelope technique. The injections in both groups will be stopped before the skin is closed. Both patients and anesthesiologists blinded the study drug (dexmedetomidine or placebo) by infusion of solution (dexmedetomidine or placebo). Depending on the size in ml, to ensure that there is no bias and blindness to the medical team about what the drug is.

Also known as: Precedex

The dexmedetomidine group:

Placebo DRUG

The same anesthesia, the same amount of Saline solution will be administered, instead of dexmedetomidine, with the same protocol

Also known as: Saline

The Placebo group (the control group):

Eligibility Criteria

• Age: 1 Day - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• As per the American Society of Anesthesiologists (ASA) classification I-I physical condition children undergoing thoracic surgery with OLV.
• From one day old to 12 years old.
• There is no prejudice in terms of gender.
• This study practically does not exclude any child who will undergo OLV even in the presence of cardiac, renal or hepatic diseases.
• Or even in the presence of cardiac stimulants and supports (dopamine or dopamine), provided that the general condition is stable, which allows surgery and OLV.

You may not qualify if:

• Premature infants: due to immaturity of the lung and insufficient formation of the surfactant.
• Cystic Fibrosis: The depressor for surfactant and lung immaturity is not permitted to perform the OLV technique
• There is no contraindication for the administration of dexmedetomidine in children except those who show signs of allergy to the dexmedetomidine.
• This study does not exclude practically any child who will undergo OLV.
• During operating surgery: The child is excluded from the study if hypoxia occurs (SpO2 \<90%) and did not respond to maneuvers and anesthetic techniques (Increase PEEP Increase the FLOW, Tidal volume, increase Vt, Pmax increased pressure, FiO2 increased) Then the lungs are periodically ventilated with positive pressure, and the OLV technique is switched off and the child is excluded from the pilot study.
• During operating surgery: If there is a drop-in heart rate less than 60 beats / minute and it does not respond to atropine or an increased dose of Cardiac tonics (dopamine).
• At this time the infusion of dexmedetomidine is stopped, it is assumed that there is no very slow pulse, and if it does, it is likely that the primary cardiac lesion is the cause.

Sponsors & Collaborators

• Damascus University: lead
• University Children's Hospital: collaborator

Study Sites (1)

University Children's Hospital

Damascus, Syria

Location

Related Publications (9)

• Asri S, Hosseinzadeh H, Eydi M, Marahem M, Dehghani A, Soleimanpour H. Effect of Dexmedetomidine Combined with Inhalation of Isoflurane on Oxygenation Following One-Lung Ventilation in Thoracic Surgery. Anesth Pain Med. 2020 Feb 12;10(1):e95287. doi: 10.5812/aapm.95287. eCollection 2020 Feb.

  PMID: 32309196 BACKGROUND

• Huang SQ, Zhang J, Zhang XX, Liu L, Yu Y, Kang XH, Wu XM, Zhu SM. Can Dexmedetomidine Improve Arterial Oxygenation and Intrapulmonary Shunt during One-lung Ventilation in Adults Undergoing Thoracic Surgery? A Meta-analysis of Randomized, Placebo-controlled Trials. Chin Med J (Engl). 2017 Jul 20;130(14):1707-1714. doi: 10.4103/0366-6999.209891.

  PMID: 28685722 BACKGROUND

• Lin J, Li JB, Lu Z. Clinical application and effect of dexmedetomidine in combination with continuous positive airway pressure on one-lung ventilation in lung surgery of elder patients. Pak J Pharm Sci. 2018 Nov;31(6(Special)):2879-2883.

  PMID: 30630803 BACKGROUND

• Meng J, Lv Q, Yao J, Wang S, Yang K. Effect of Dexmedetomidine on Postoperative Lung Injury during One-Lung Ventilation in Thoracoscopic Surgery. Biomed Res Int. 2020 Oct 5;2020:4976205. doi: 10.1155/2020/4976205. eCollection 2020.

  PMID: 33083468 BACKGROUND

• Shen Q, Xu G, Liu J, Wang L, Zhou Y, Yu Y, Lv C, Liu X. Dexmedetomidine alleviates non-ventilation associated lung injury via modulating immunology phenotypes of macrophages. Life Sci. 2020 Oct 15;259:118249. doi: 10.1016/j.lfs.2020.118249. Epub 2020 Aug 13.

  PMID: 32798558 BACKGROUND

• Sheybani S, Attar AS, Golshan S, Sheibani S, Rajabian M. Effect of propofol and isoflurane on gas exchange parameters following one-lung ventilation in thoracic surgery: a double-blinded randomized controlled clinical trial. Electron Physician. 2018 Feb 25;10(2):6346-6353. doi: 10.19082/6346. eCollection 2018 Feb.

  PMID: 29629058 BACKGROUND

• Wang J, Yi X, Jiang L, Dong H, Feng W, Wang S, Chu C. Protective effects of dexmedetomidine on lung in rats with one-lung ventilation. Exp Ther Med. 2019 Jan;17(1):187-192. doi: 10.3892/etm.2018.6952. Epub 2018 Nov 9.

  PMID: 30651781 BACKGROUND

• Xie Y, Jiang W, Zhao L, Wu Y, Xie H. Effect of dexmedetomidine on perioperative inflammation and lung protection in elderly patients undergoing radical resection of lung cancer. Int J Clin Exp Pathol. 2020 Oct 1;13(10):2544-2553. eCollection 2020.

  PMID: 33165407 BACKGROUND

• Xu B, Gao H, Li D, Hu C, Yang J. Nebulized dexmedetomidine improves pulmonary shunt and lung mechanics during one-lung ventilation: a randomized clinical controlled trial. PeerJ. 2020 Jun 5;8:e9247. doi: 10.7717/peerj.9247. eCollection 2020.

  PMID: 32547872 BACKGROUND

MeSH Terms

Conditions

Esophageal Atresia; Hidrocystoma; Abscess

Interventions

Dexmedetomidine; Sodium Chloride

Condition Hierarchy (Ancestors)

Digestive System Abnormalities; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Adenoma, Sweat Gland; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Adnexal and Skin Appendage; Suppuration; Infections; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Faten Rostom, PHD

  Head of the Department of Anesthesiology Al-Assad University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple masking: Anesthesiologists, graduate students, anesthesiologists, patients and their families will not know if a child is taking the drug or not. Also, the person who will conduct the survey will not know either, all will be hidden. Depending on the volume in ml, to mask the medical team from the substance of the drug...
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2021
• First Posted: June 21, 2021
• Study Start: March 1, 2021
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: February 17, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)