Association Between Preoperative Insomnia and Postoperative Quality of Recovery : A Prospective Observational Study

Trial Title: Association Between Preoperative Insomnia and Postoperative Quality of Recovery : A Prospective Observational Study

NCT ID: NCT06008873

Condition: Sleep Disorder

Conditions: Official terms:
Sleep Initiation and Maintenance Disorders
Sleep Wake Disorders

Conditions: Keywords:
Insomnia
Perioperative Medicine
cancer
surgery
Quality of Recovery

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Summary: Although patients with cancers are prone to insomnia, especially waiting for surgery during hospitalization, and insomnia promotes acute respiratory infections (ARI) and is not conducive to the postoperative quality of recovery (QoR), evidence that preoperative insomnia delays postoperative recovery is still lacking. In this prospective observational study, we enroll 175 non-elderly subjects with abdominal cancer who will undergo non-emergency cancer resection surgery. Insomnia Severity Index scale (ISI) is used to assess the insomnia severity during hospitalization while awaiting surgery. The Quality of Recovery-15 (QoR-15) is used to evaluate the overall recovery after surgery. Meanwhile, wrist watch and sleep diary are used to record sleep. The aim of the study is to investigate the association between preoperative insomnia and postoperative QoR, the association between preoperative insomnia and postoperative ARI,and to describe preoperative sleep traits.

Detailed description: In the single-center, prospective observational study, ISI is used to investigate the perceptive sleep during hospitalization waiting for surgery,and QoR-15 is used to investigate the overall quality of functional recovery at postoperative 1, 3, 7, 14, and 30 days (POD1/3/7/14/30). At the same time, both of ARI within POD30 and neutrophil to lymphocyte ratio(NLR) in peripheral blood perioperation are recorded. The study is divided into four phases: (1) Screening: on the first day of admission, the subjects are screened according to the inclusion and exclusion criteria, and the basic data are collected, including ISI, QoR-15 and depression/anxiety questionnaires, et al. (2) Enrollment (sleep survey during hospitalization waiting for surgery) : ISI is performed in the day of surgery to perceive the severity of insomnia during the whole period of hospitalization waiting for surgery, and objective and subjective sleep are investigated by wrist watch and sleep diary. (3) Surgical and anesthesia period: the key medical data related to surgery, anesthesia and nursing occurred during the operation are recorded. (4) Follow-up: QoR-15 is investigated POD1/3/7/14/30. Meanwhile, both of ARI and NLR are investigated. The planned enrollment is 175 subjects. No randomized or any protocol-driven treatment is administered to the subjects during the study. The effect size f2 of the independent variable (ISI scores of hospitalization waiting for surgery) on the dependent variable (QoR-15 on POD1) is expected to be 0.1. The number of covariates is predicted to be 46, α is set as two-sided 0.05, and the power is 0.9. The sample size calculated by PASS software is 157 cases. Considering 10% dropout, a sample size of 175 will be required. Data will be presented as mean±standard deviation, median and number (%). Logistic multivariate, or multivariable models will be both performed by statisticians.

Criteria for eligibility:

Study pop:
Referred to the Eligibility Criteria for details.

Sampling method: Non-Probability Sample
Criteria:
Inclusion Criteria: - 1.Voluntarily execute informed consent; - 2.Effective linguistic communication and collaboration; - 3.No history of mental disorders; - 4.Age of 18-64 years old, male or female; - 5.BMI 18-30kg/m2; - 6.American Society of anesthesiology (ASA) grade 1-2, New York Heart Association(NYHA) grade Ⅰ or Ⅱ; - 7.Initial diagnosis of abdominal cancers and the diagnosis has been disclosed to subjects; - 8.Non-emergency cancer resection surgery is planned; - 9.The planned anesthesia is general anesthesia with endotracheal intubation. Exclusion Criteria: - 1.Obstructive apnea syndrome, narcolepsy, restless leg/periodic limb movement disorder, sleepwalking disorder, nightmare disorder; - 2.Not suitable to participate in the study.

Gender: All

Minimum age: 18 Years

Maximum age: 64 Years

Healthy volunteers: No

Locations:

Facility:
Name: the Sixth Affiliated Hospital, Sun Yat-sen University

Address:
City: Guangzhou
Zip: 510655
Country: China

Status: Recruiting

Contact:
Last name: SanQing Jin, MD

Phone: 0086-13719366863
Email: sanqingjin@hotmail.com

Start date: February 15, 2023

Completion date: October 2023

Lead sponsor:
Agency: Sixth Affiliated Hospital, Sun Yat-sen University
Agency class: Other

Source: Sixth Affiliated Hospital, Sun Yat-sen University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06008873