Clinical trial NCT06008873: Association Between Preoperative Insomnia and Postoperative Quality of Recovery : A Prospective Observational Study
Official title: Association Between Preoperative Insomnia and Postoperative Quality of Recovery in Non-elderly Patients Undergoing Non-emergency Cancer Resection Surgery: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Disorder
Keywords: Insomnia
Perioperative Medicine
cancer
surgery
Quality of Recovery
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2023-08-24
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Referred to the Eligibility Criteria for details.

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Total scores of the questionnaire of Insomnia Severity Scale (ISI) on the day before surgery or the day of surgery
timeFrame: on the day before surgery or the day of surgery
measure: Total scores of the questionnaire of 15-item Quality of Recovery scale (QoR-15）on postoperative day 1
timeFrame: on postoperative day 1
Secondary outcomes:
measure: Sleep-onset latency(min)(resulting from CSD): Distribution frequency of different degrees of sleep latency during the time when waiting for surgery in hospital from the day of admission to the day of surgery
timeFrame: Everyday when waiting for surgery in hospital from the day of admission to the day of surgery
measure: Numbers of awakenings(resulting from CSD): Distribution of Numbers of awakenings during the time when waiting for surgery in hospital from the day of admission to the day of surgery
timeFrame: Everyday when waiting for surgery in hospital from the day of admission to the day of surgery
measure: Total duration of sleep in night(min)(resulting from CSD): Distribution of total duration of sleep in night during the time when waiting for surgery in hospital from the day of admission to the day of surgery
timeFrame: Everyday when waiting for surgery in hospital from the day of admission to the day of surgery
measure: Sleep influencing factors(resulting from CSD): Distribution of factors that could influence sleep in night when waiting for surgery in hospital from the day of admission to the day of surgery
timeFrame: Everyday when waiting for surgery in hospital from the day of admission to the day of surgery
measure: Total scores of the questionnaire of 15-item Quality of Recovery scale (QoR-15）on postoperative day 3
timeFrame: on postoperative day 3
measure: Total scores of the questionnaire of 15-item Quality of Recovery scale (QoR-15）on postoperative day 7
timeFrame: on postoperative day 7
measure: Total scores of the questionnaire of 15-item Quality of Recovery scale (QoR-15）on postoperative day 14
timeFrame: on postoperative day 14
measure: Total scores of the questionnaire of 15-item Quality of Recovery scale (QoR-15）on postoperative day 30
timeFrame: on postoperative day 30
measure: Incidence rate of Acute Respiratory Tract Infection (ARTI) within postoperative day 30
timeFrame: within postoperative day 30
measure: Peripheral blood neutrophil/lymphocyte ratio on postoperative day 1
timeFrame: on postoperative day 1
measure: Peripheral blood neutrophil/lymphocyte ratio on postoperative day 3
timeFrame: on postoperative day 3
measure: Peripheral blood neutrophil/lymphocyte ratio on postoperative day 7
timeFrame: on postoperative day 7
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: the Sixth Affiliated Hospital, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: The Sixth Affiliated Hospital, Sun Yat-sen University
name: Jin sanqing, MD
role: PRINCIPAL_INVESTIGATOR
References: