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

NCT06008873 | Completed

• 1 other identifier: 2023ZSLYEC-260
• Study Type: observational
• Target: 198
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Disorder

Keywords

Insomnia; Perioperative Medicine; cancer; surgery; Quality of Recovery

Outcome Measures

Primary Outcomes (2)

• Total scores of the questionnaire of Insomnia Severity Scale (ISI) on the day before surgery or the day of surgery

  ISI is used to assess insomnia during the time when waiting for surgery in hospital from the day of admission to the day of surgery. ISI is used to assess how satisfied with sleep patterns and psychological distress or impairments in daytime functioning associated with sleep difficulties. ISI is filled in by subjects on the day before surgery or the day of surgery. ISI contents 7 items, which item is measured by an 0-4 point rating scale (0="very satisfaction"; 4="very dissatisfaction"). ISI total scores range from 0 to 28, with higher scores indicating higher severity of insomnia.

  on the day before surgery or the day of surgery

• Total scores of the questionnaire of 15-item Quality of Recovery scale (QoR-15）on postoperative day 1

  QoR-15 is a patient-reported measure, and is used to assess global recovery quality after surgery physiologically and psychologically. QoR-15 is filled on postoperative day 1. QoR-15 contents 15 items, which item is constructed by an 11-point numerical rating scale (for positive items, 0= "none of the time" to 10="all of the time"; for negative items the scoring was reversed). The total scores are ranging from 0(extremely poor QoR) to 150 (excellent QoR).

  on postoperative day 1

Secondary Outcomes (12)

• 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

  Everyday when waiting for surgery in hospital from the day of admission to the day of surgery

• 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

  Everyday when waiting for surgery in hospital from the day of admission to the day of surgery

• 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

  Everyday when waiting for surgery in hospital from the day of admission to the day of surgery

• 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

  Everyday when waiting for surgery in hospital from the day of admission to the day of surgery

• Total scores of the questionnaire of 15-item Quality of Recovery scale (QoR-15）on postoperative day 3

  on postoperative day 3

Study Arms (1)

One group only

No intervention.

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Referred to the Eligibility Criteria for details.

You may qualify if:

• Voluntarily execute informed consent;
• Effective linguistic communication and collaboration;
• No history of mental disorders;
• Age of 18-64 years old, male or female;
• BMI 18-30kg/m2;
• American Society of anesthesiology (ASA) grade 1-2, New York Heart Association(NYHA) grade Ⅰ or Ⅱ;
• Initial diagnosis of abdominal cancers and the diagnosis has been disclosed to subjects;
• Non-emergency cancer resection surgery is planned;
• The planned anesthesia is general anesthesia with endotracheal intubation.

You may not qualify if:

• Obstructive apnea syndrome, narcolepsy, restless leg/periodic limb movement disorder, sleepwalking disorder, nightmare disorder;
• Not suitable to participate in the study.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

the Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

Location

MeSH Terms

Conditions

Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders; Neoplasms

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias

Study Officials

• Jin sanqing, MD

  The Sixth Affiliated Hospital, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: August 13, 2023
• First Posted: August 24, 2023
• Study Start: February 15, 2023
• Primary Completion: August 12, 2023
• Study Completion: September 10, 2023
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)