NCT04619979

Preoperative Anxiety on Postoperative Outcome and Sleep Quality in Patients Undergoing Laparoscopic Hysterectomy

Completed Last updated 17 August 2022

What this trial tests

trial testing patients undergoing gynecological surgery under general anesthesia in General Anesthesia in 356 participants. Completed in 10 August 2022.

Timeline

1 October 2021

Primary endpoint
1 March 2022

10 August 2022

Quick facts

Lead sponsor	Shengjing Hospital
Status	Completed
Study type	OBSERVATIONAL
Enrollment	356
Start date	1 October 2021
Primary completion	1 March 2022
Estimated completion	10 August 2022
Sites	1 location across China

Drugs / interventions tested

• patients undergoing gynecological surgery under general anesthesia

Conditions studied

• General Anesthesia — all drugs for General Anesthesia →
• Postoperative Pain — all drugs for Postoperative Pain →
• Postoperative Sleep Quality — all drugs for Postoperative Sleep Quality →
• Preoperative Anxiety — all drugs for Preoperative Anxiety →

Sponsor

Shengjing Hospital

Who can join

Adults 18 to 75, any sex, with General Anesthesia or Postoperative Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Sleep is a naturally occurring state of decreased arousal that is crucial for normal immune and cognitive function. Although surgery and anesthesia techniques have improved in recent years, sleep function and sleep cycles may still be altered perioperatively by surgery and other interventions under general anesthesia.Postoperative sleep fragmentation and poor sleep quality not only lead to hyperalgesia and delayed postoperative recovery, but can increase the risk of potential adverse effects, such as cognitive impairment, chronic pain and emotional disturbances, metabolic disorders, and pro-inflammatory changes. General anesthesia is a medically induced state of hyporesponsiveness that resembles natural sleep. Studies have shown that general anesthesia can lead to circadian rhythm time structure dyssynchrony, resulting in postoperative sleep disturbance, characterized by decreases in rapid eye movement (REM) and slow wave sleep (SWS). Previous studies have also reported that age, preoperative comorbidities, and severity of surgical trauma are independent factors associated with postoperative sleep disturbance. In addition, anxiety is an unpleasant sensation that compromises patients' comfort and well-being. A study by Ruis et al. estimated that 25-80% of patients admitted for surgery experienced preoperative anxiety, including fear of surgery and anesthesia-related fears. Furthermore, preoperative anxiety was recognized as a potential and preventable risk factor for severe postoperative pain and postoperative complications such as increased postoperative morbidity and mortality. Given that several prior studies have reported that preoperative anxiety has an effect on postoperative sleep quality in patients undergoing gynecological surgery, this study aimed to investigate the effect of preoperative anxiety on postoperative outcomes and sleep quality in patients undergoing gynecological surgery. Studying these results could enable us to better manage patients during the perioperative period to promote their postoperative recovery.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effects of Preoperative Anxiety on Postoperative Outcomes and Sleep Quality in Patients Undergoing Laparoscopic Gynecological Surgery.
   Gu X, Zhang Y, Wei W, Zhu J. · · 2023 · cited 39× · PMID 36902622 · DOI 10.3390/jcm12051835