Dreaming During Anesthesia and Anesthetic Depth in Elective Surgery Patients Under General Anesthesia

NCT ID: NCT05357872

Last Updated: 2022-05-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2022-07-31

Brief Summary

Dreaming is a common, enduring, and fascinating part of the anesthetic experience, but its cause and timing remain elusive. Patients typically report that they were dreaming during anesthesia, but the actual timing of anesthetic dreaming is unknown. The following evidence supports the hypothesis that dreaming occurs intraoperatively and is related to light or inadequate anesthesia: (1) The incidence of dreaming has decreased as anesthetic techniques have improved; (2) dreamers exhibit more clinical signs of light anesthesia or report more awareness than non dreamers; (3) dreamers may receive lower doses of anesthetic drugs than non dreamers and emerge more rapidly from anesthesia; (4) the content of dreams may involve surgical topics or events occurring during anesthesia; and (5) in one study, the incidence of dreaming was lower in Bispectral Index (BIS)-monitored patients. Alternatively, dreaming may occur during emergence from anesthesia, when the brain is still affected by sedative concentrations of anesthetic drugs and the patient enters a sleep state. Few studies have assessed the relation between dreaming and depth of anesthesia, and their results were inconclusive.Most recently, in the B-Aware Trial, no differences in depth of anesthesia, as measured by BIS, were detected between dreamers and non dreamers. However, the patients were at high risk of awareness, and BIS data were collected manually and were only recorded in the BIS group and during maintenance. No studies investigating the relation between dreaming and depth of anesthesia during recovery were identified. Why is the investigation of dreaming during anesthesia important? Dreaming is one of the most common side effects of anesthesia but remains puzzling and requires explanation. Dreaming is sometimes distressing to patients and may decrease satisfaction with care. Some patients who report dreaming fear that their anesthetic was inadequate and that their experience was, in fact, awareness. Indeed, in a minority of cases, dreaming may truly represent near-miss awareness. The investigators therefore tested the hypothesis that dreaming during anesthesia is associated with light or inadequate anesthesia, as evidenced by higher median BIS values during maintenance of anesthesia. The investigators also explored the depth of anesthesia until emergence, the form and content of dreams, the predictors of dreaming during anesthesia, and the effect of dreaming on quality of recovery and satisfaction with anesthetic care

Conditions

Dreaming; General Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

BIS 40-50 Group

The anesthesiologist adjusted the intravenous speed of remifentanil and propofol to maintain the bispectral index (BIS, BIS monitor; Aspect Medical System, Newton, MA) between 40-50

Group Type: EXPERIMENTAL

deep anesthesia depth

Intervention Type: DEVICE

The anesthesiologist adjusted the intravenous speed of remifentanil and propofol to maintain the bispectral index (BIS, BIS monitor; Aspect Medical System, Newton, MA) between 40-50 and 50-60 during the operation.

BIS 50-60 Group

The anesthesiologist adjusted the intravenous speed of remifentanil and propofol to maintain the bispectral index (BIS, BIS monitor; Aspect Medical System, Newton, MA) between 50-60 during the operation.

Group Type: EXPERIMENTAL

light anesthesia depth

Intervention Type: DEVICE

The anesthesiologist adjusted the intravenous speed of remifentanil and propofol to maintain the bispectral index (BIS, BIS monitor; Aspect Medical System, Newton, MA) between 40-50 and 50-60 during the operation.

Interventions

deep anesthesia depth

The anesthesiologist adjusted the intravenous speed of remifentanil and propofol to maintain the bispectral index (BIS, BIS monitor; Aspect Medical System, Newton, MA) between 40-50 and 50-60 during the operation.

Intervention Type: DEVICE

light anesthesia depth

The anesthesiologist adjusted the intravenous speed of remifentanil and propofol to maintain the bispectral index (BIS, BIS monitor; Aspect Medical System, Newton, MA) between 40-50 and 50-60 during the operation.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• between 18 and 70 years
• with an ASA physical status of I or II

Exclusion Criteria

• presence of sleep disorders
• pain syndrome
• cardiovascular disease
• sleep apnea syndrome
• psychosis
• history of opioid usage
• history of abnormal operation or anesthesia recovery
• unwillingness to provide informed consent
• a patient with a language communication disorder

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shengjing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yanchao Yang

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

junchao zhu

Role: PRINCIPAL_INVESTIGATOR

Shengjing Hospital

Locations

Shengjing Hospital

Shenyang, Liaoning, China

Site Status: RECRUITING

Countries

China

Central Contacts

junchao zhu

Role: CONTACT

zhujunchao1@hotmail.com

+8618940257257

Facility Contacts

junchao zhu

Role: primary

zhujunchao1@hotmail.com

+8618940257257

Other Identifiers

BIS and dream

Identifier Type: -

Identifier Source: org_study_id