Dexmedetomidine Improved Oxygenation and Reduced Shunt in One-Lung Ventilation at High-Risk Pediatric Thoracic Surgery

NCT06505772 | Completed

• 1 other identifier: UDMS-Anesth-02-2024
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

Children with high anesthetic risk who underwent Thoracic surgery with OLV (one lung ventilation) technique during general anesthesia were divided into two groups. The first is an intravenous injection of dexmedetomidine at a rate of 0.4 micrograms/kg/hour as a continuous intravenous infusion. The second group, the placebo group, injected the second with a normal saline solution, an infusion that will pass through the vein, using blinded, unmarked syringes. Three arterial blood gas (ABG) samples were taken during surgery at designated times. Circulatory PaO2 values were recorded and the Qs/Qt shunt value was calculated.

Conditions

One-Lung Ventilation; Thoracic Surgery

Keywords

Hypoventilation pulmonary vasoconstriction HPV; Pulmonary shunt fraction Qs/Qt; Dexmedetomidine; partial pressure of arterial oxygen (PaO2)

Outcome Measures

Primary Outcomes (2)

• Change in the PaO2

  Evaluation of Change in PaO2 During Surgery. PaO2: is Partial Pressure of Arterial Oxygen.

  four time points: (T1) 10 minutes after initiation of total lung ventilation (TLV), (T2) 10 minutes after initiation of one-lung ventilation (OLV), (T3) 60 minutes after initiation of OLV, and (T4) 20 minutes after the end of OLV.

• Change in the Qs/Qt

  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.

  four time points: (T1) 10 minutes after initiation of total lung ventilation (TLV), (T2) 10 minutes after initiation of one-lung ventilation (OLV), (T3) 60 minutes after initiation of OLV, and (T4) 20 minutes after the end of OLV.

Secondary Outcomes (3)

• Change in the PIP

  four time points: (T1) 10 minutes after initiation of total lung ventilation (TLV), (T2) 10 minutes after initiation of one-lung ventilation (OLV), (T3) 60 minutes after initiation of OLV, and (T4) 20 minutes after the end of OLV.

• Change in the MAP

  four time points: (T1) 10 minutes after initiation of total lung ventilation (TLV), (T2) 10 minutes after initiation of one-lung ventilation (OLV), (T3) 60 minutes after initiation of OLV, and (T4) 20 minutes after the end of OLV.

• Change in the HR

  four time points: (T1) 10 minutes after initiation of total lung ventilation (TLV), (T2) 10 minutes after initiation of one-lung ventilation (OLV), (T3) 60 minutes after initiation of OLV, and (T4) 20 minutes after the end of OLV.

Study Arms (2)

The dexmedetomidine group

EXPERIMENTAL

Dexmedetomidine: An initial dose of 0.5 mcg/kg of dexmedetomidine will be given over 10 minutes, starting 10 minutes after the initiation of anesthesia infusion. Following the initial dose, a continuous infusion of dexmedetomidine will be administered at a rate of 0.4 mcg/kg/hour. The infusion will be stopped before skin closure.

Drug: Dexmedetomidine

The Placebo group (the control group):

PLACEBO COMPARATOR

Saline Solution (Placebo): After the induction of anesthesia, a volume of saline solution equivalent to the volume of dexmedetomidine used in the experimental group will be administered using the same protocol.

Drug: Normal saline

Interventions

Dexmedetomidine DRUG

Infusion syringes are supplied with a concentration of 0.25 mcg / mL (dexmedetomidine ) either 80 mcg / 20 mL, 200 mcg / 50 mL, or 400 mcg / 100 mL. For example, it begins with an infusion of 4 ml over 10 minutes and then continues the infusion, depending on the weight of the child, at a rate of 1.6 ml/kg/hour. 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

Normal saline DRUG

Normal saline (NS) for intravenous infusion is supplied in pre-filled syringes of 20 ml, 50 ml, and 100 ml. To maintain blinding in this study, NS is handled identically to the study drug, dexmedetomidine. A physician not involved in the study prepares all injections, randomly assigning either NS or dexmedetomidine using a sealed envelope technique. Prepared syringes are then placed in identical, unmarked infusion pumps. Infusion Protocol: Anesthesiologists, blinded to the infusion contents, administer the solutions according to the protocol: For example,Initial Bolus: 4 ml infused over 10 minutes, Maintenance Infusion: Continued at a rate of 1.6 ml/kg/hour, adjusted to the individual patient's weight. This process ensures both patient and anesthesiologist remain blinded to the treatment arm, minimizing potential bias throughout the study.

Also known as: Placebo

The Placebo group (the control group):

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children with American Society of Anesthesiologists (ASA) grade III
• FEV1/FVC values less than 80% . FEV1/FVC ratio represents the proportion of the total vital capacity that can be exhaled in the first second of forced expiration, whereas FEV1 indicates "Force Expiratory Volume in 1 second" and FVC indicates "Forced Vital Capacity".
• Qs/Qt ratio greater than 10 .

You may not qualify if:

• renal failure.
• hepatic dysfunction.
• congenital and valvular cardiac disease.
• neurological illnesses.
• During surgery, individuals who did not achieve complete lung isolation were excluded.
• During surgery, individuals with poor oxygen saturation (SO2 \<90%) who did not react to maneuvers and anesthetic procedures to boost saturation were removed.
• During surgery, Participants who had a heart rate of less than 80 beats per minute, did not react to atropine, or required a dosage of inotropic drugs (dopamine) were also removed from the trial.

Sponsors & Collaborators

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

Study Sites (1)

University Children's Hospital

Damascus, Syria

Location

Related Publications (9)

• Licker M, Hagerman A, Jeleff A, Schorer R, Ellenberger C. The hypoxic pulmonary vasoconstriction: From physiology to clinical application in thoracic surgery. Saudi J Anaesth. 2021 Jul-Sep;15(3):250-263. doi: 10.4103/sja.sja_1216_20. Epub 2021 Jun 19.

  PMID: 34764832 BACKGROUND

• Kim D, Lee C, Bae H, Kim J, Oh EJ, Jeong JS. Comparison of the perfusion index as an index of noxious stimulation in monitored anesthesia care of propofol/remifentanil and propofol/dexmedetomidine: a prospective, randomized, case-control, observational study. BMC Anesthesiol. 2023 May 26;23(1):183. doi: 10.1186/s12871-023-02116-x.

  PMID: 37237353 BACKGROUND

• Mahmoud M, Barbi E, Mason KP. Dexmedetomidine: What's New for Pediatrics? A Narrative Review. J Clin Med. 2020 Aug 24;9(9):2724. doi: 10.3390/jcm9092724.

  PMID: 32846947 BACKGROUND

• De Cassai A, Boscolo A, Geraldini F, Zarantonello F, Pettenuzzo T, Pasin L, Iuzzolino M, Rossini N, Pesenti E, Zecchino G, Sella N, Munari M, Navalesi P. Effect of dexmedetomidine on hemodynamic responses to tracheal intubation: A meta-analysis with meta-regression and trial sequential analysis. J Clin Anesth. 2021 Sep;72:110287. doi: 10.1016/j.jclinane.2021.110287. Epub 2021 Apr 16.

  PMID: 33873003 BACKGROUND

• Khddam A, Rostom F, Hajeer MY. Effect of Dexmedetomidine on Oxygen and Intrapulmonary Shunt (Qs/Qt) During One-Lung Ventilation in Pediatric Surgery: A Randomized Controlled Trial. Cureus. 2024 Mar 22;16(3):e56693. doi: 10.7759/cureus.56693. eCollection 2024 Mar.

  PMID: 38523877 BACKGROUND

• Wang Y, Gong C, Yu F, Zhang Q. Effect of dexmedetomidine on intrapulmonary shunt in patients with sevoflurane maintained during one-lung ventilation: A case-control study. Medicine (Baltimore). 2022 Nov 18;101(46):e31818. doi: 10.1097/MD.0000000000031818.

  PMID: 36401465 BACKGROUND

• 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

• 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

• 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

MeSH Terms

Interventions

Dexmedetomidine; Saline Solution

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Faten Rostom, PHD

  Department of Anesthesiology Faculty of Medicine Damascus University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 17, 2024
• Study Start: March 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: July 1, 2024
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)