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Effects of Small-dose S-ketamine on Anesthesia-induced Atelectasis in Anesthetized Patients Accessed by Pulmonary Ultrasound

NCT04745286 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-02-09

No results posted yet for this study

Summary

Background: Atelectasis occurs in the majority of patients with general anesthesia, which can lead to postoperative pulmonary complications (PPCs) and affect the postoperative outcome. However, there is still no exact method to prevent it though agents. S-ketamine may prevent atelectasis due to its airway smooth muscle relaxation and anti-inflammatory effects. Lung ultrasound is a portable and reliable bedside imaging technology for diagnosing anesthesia-induced atelectasis. Here, we intend to assess whether small-dose of S-ketamine can reduce the incidence of atelectasis after intubation under general anesthesia using lung ultrasound, in order to prevent the early formation of perioperative atelectasis and perioperative pulmonary complications.

Methods: The trial is a single institution, prospective, randomized controlled, parallel grouping, double-blind study. From October 2021 to March 2022, 100 patients (18-60 years old) scheduled for elective surgery will be recruited from Beijing Tiantan Hospital, Capital Medical University, and randomly assigned to the S-ketamine group (Group S) and the normal saline group (Group N) at a ratio of 1:1. The label-masked agents will be given 5 minutes before induction and all patients will undergo a standardized general anesthesia protocol. Related data will be collected at three time point: after radial artery puncture (T1), 15 minutes after tracheal intubation (T2) and before extubation (T3). The primary outcome will be the total LUS scores at T2. Secondary outcomes include LUS scores in 6 chest regions at T2; total LUS scores at T3; arterial blood-gas analysis results (PaCO2, PaO2) and PaO2/FiO2 at T2 and T3, plateau pressure(Pplat) and dynamic lung compliance (Cdyn) at T2 and T3; the incidence of postoperative complications associated with S-ketamine and postoperative pulmonary complications (PPCs) 2 and 24 hours after surgery；.

Discussion: This trial aims to explore whether a simple and feasible application of S-ketamine before the induction of general anesthesia can prevent atelectasis. The results of this study may provide new ideas and direct clinical evidence for the prevention and treatment of perioperative pulmonary complications during anesthesia.

Key words: atelectasis, S-ketamine, ultrasound, RCT, protocol

Conditions

  • Atelectasis

Interventions

DRUG

S-ketamine

Patients will receive the label-covered trial agent covered by the label after premedication 5 min before induction. Agent preparation method of S-ketamine group (Group S): Draw the dosage of S-ketamine 0.25mg ·kg -1 and dilute it with normal saline to 5ml in opaque 5-ml syringes.

DRUG

normal saline group

Patients will receive the label-covered trial agent covered by the label after premedication 5 min before induction. Normal saline group (Group N): 5ml of normal saline, labeled as "study agents".

Sponsors & Collaborators

  • Beijing Tiantan Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-31
Primary Completion
2021-10-31
Completion
2022-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04745286 on ClinicalTrials.gov