Impact of Maxigesic on Delirium After Minimally Invasive Lung Surgery in Elderly Patients

Phase 4TerminatedNCT05834569

Korea University Guro Hospital25 enrolled

Overview

The primary aim of this interventional study is to investigate the impact of perioperative administration of Maxigesic (combination of acetaminophen and ibuprofen) on delirium after minimally invasive lung surgery in elderly patients. The Maxigesic group receives a total of 5 doses of Maxigesic (20mg/kg, maximum dose per serving: 1g) every 6 h from immediately after anesthesia induction. The control group receives the same volume of normal saline. Researchers compare the incidence and severity of postoperative delirium for 5 days after surgery.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Delirium Aged Lung Neoplasms Robotic Surgical Procedures Thoracic Surgery, Video-Assisted

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients aged 65 years or older undergoing minimally invasive lung lobectomy or segmentectomy Exclusion Criteria: * Hypersensitivity to the main ingredients and additives of Maxigesic * Hypersensitivity to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) * Alcoholism / Alcohol intoxication * Severe hematological abnormalities * Bleeding tendency (e.g., Spontaneous bleeding) * Severe hepatic dysfunction (AST, AST ≥2.5 \* upper normal limit(UNL) or Total bilirubin ≥3.0 mg/dl) * Severe renal dysfunction (eGFR \<30 ml/min/1.73m2 or Dialysis) * Severe heart failure (Left ventricle ejection fraction \<30%) * Uncontrolled hypertension(HTN) (Systolic blood pressure \>180 mmHg) * Symptomatic asthma in need of treatment * Anticoagulants or antiplatelet agents are maintained for up to 5 days before surgery * Barbiturates or tricyclic antidepressants (TCAs) * High-dose methotrexate (MTX) for cancer treatment * Preoperative cognitive impairment, dementia, or delirium * Inability to understand the research and instructions for this study

Outcomes

Primary Outcomes

Incidence of postoperative delirium(POD)

Confusion assessment method(CAM)/Confusion Assessment Method for the ICU (CAM-ICU) or delirium record on electrical medical record(EMR) will be used for the evaluation of POD.

Time frame: From immediately after surgery to 5 days after surgery

Secondary Outcomes

Severity of POD

CAM-S(severity) will be utilized to assess the severity of POD. (\*CAM-S is measured on 0-7 (short form) and 0-19 (long form) scale, and the higher the score, the greater the POD severity.)

Time frame: From immediately after surgery to 5 days after surgery

Duration of POD

CAM/CAM-ICU or delirium record on EMR will be used to estimate the duration of POD.

Time frame: From immediately after surgery to 5 days after surgery

Preoperative cognition

Mini-mental state examination(MMSE) will be used to evaluate the participants' preoperative cognition. (\*MMSE is measured on 0-30 scale, and the lower the score, the more cognitively impaired the patient is.)

Time frame: 1 day before surgery

Preoperative cognition

Montreal cognitive assessment(MoCA) will be used to evaluate the participants' preoperative cognition. (\*MoCA is measured on 0-30 scale, and the lower the score, the more cognitively impaired the patient is.)

Time frame: 1 day before surgery

Preoperative frailty

Clinical frailty scale(CFS) will be utilized to assess the preoperative frailty (\*CFS is used to determine comprehensive geriatric assessment. It is measured on 1-9 scale, and the higher the scale, the more frail the patient is.)

Time frame: 1 day before surgery

Postoperative pain

Numerical rating scale (NRS) or Visual analogue scale (VAS) will be used to determine the postoperative pain severity (\*NRS and VAS are measured on a 0-10 scale, and the higher the score, the more severe the patient's pain. If the patient can verbalize their pain, use the NRS; otherwise, use the VAS to assess pain).

Time frame: Immediately after surgery to postoperative 48 hours

Consumption of opioids

Opioid consumption is measured by converting them into morphine equivalents.

Time frame: Immediately after surgery to postoperative 48 hours

Postoperative nausea, vomiting

Nausea is measured by scoring on a scale of 0-10. The higher the score, the more severe the symptom. Whether the patients vomit or not is observed and recorded.

Time frame: Immediately after surgery to postoperative 48 hours

ICU stay

Determine how many days the participant stays in the ICU.

Time frame: Immediately after surgery to ICU discharge(usually within about 5 days after surgery)

Hospital stay

Determine how many days the participant stays in the hospital.

Time frame: Immediately after surgery to hospital discharge(usually within about 30 days after surgery)

Postoperative complications

Investigate all kinds of complications that occur after surgery.

Time frame: Immediately after surgery to hospital discharge(usually within about 30 days after surgery)

Drug side effects

Investigate complications suspected to be side effects caused by the study drug.

Time frame: Immediately after surgery to hospital discharge(usually within about 30 days after surgery)

Impact of Maxigesic on Delirium After Minimally Invasive Lung Surgery in Elderly Patients

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes