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

NCT05357872 | Unknown

• 1 other identifier: BIS and dream
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (17)

• Mean blood pressure

  record mean blood pressure during the surgery. Systolic, diastolic, or both pressures don't need to be assessed during the study period.

  5 minutes after entering the operation room

• Mean blood pressure

  record mean blood pressure during the surgery. Systolic, diastolic, or both pressures don't need to be assessed during the study period.

  procedure (anesthesia induction)

• Mean blood pressure

  record mean blood pressure during the surgery. Systolic, diastolic, or both pressures don't need to be assessed during the study period.

  at the end of surgery

• Mean blood pressure

  record mean blood pressure during the surgery. Systolic, diastolic, or both pressures don't need to be assessed during the study period.

  procedure (anesthesia extubation)

• Mean blood pressure

  record mean blood pressure during the surgery. Systolic, diastolic, or both pressures don't need to be assessed during the study period.

  the time when leaving the operation room

• heart rate

  record heart rate during the surgery

  5 minutes after entering the operation room

• heart rate

  record heart rate during the surgery

  procedure (Anesthesia induction)

• heart rate

  record heart rate during the surgery

  at the end of surgery

• heart rate

  record heart rate during the surgery

  procedure (anesthesia extubation)

• heart rate

  record heart rate during the surgery

  the time when leaving the operation room

• Bispectral Index (BIS)

  record BIS during the surgery. The range was 0-100. We control the range of BIS in 40-60 during the surgery

  5 minutes after entering the operation room

• Bispectral Index (BIS)

  record BIS during the surgery. record BIS during the surgery. The range was 0-100. We control the range of BIS in 40-60 during the surgery

  procedure (Anesthesia induction)

• Bispectral Index (BIS)

  record BIS during the surgery. record BIS during the surgery. The range was 0-100. We control the range of BIS in 40-60 during the surgery

  at the end of surgery

• Bispectral Index (BIS)

  record BIS during the surgery. record BIS during the surgery. The range was 0-100. We control the range of BIS in 40-60 during the surgery

  procedure (anesthesia extubation)

• Bispectral Index (BIS)

  record BIS during the surgery. record BIS during the surgery. The range was 0-100. We control the range of BIS in 40-60 during the surgery

  the time when leaving the operation room

• Total dose of propofol

  record total dose of propofol

  at the end of surgery

• Dream

  Dreaming during anesthesia was defined as any experience that was described by the patient as dreaming and was thought by the patient to have occurred between the induction of anesthesia and the first moment of consciousness after anesthesia.27 Awareness was defined as postoperative recall of intraoperative events. All patients who reported dreaming were considered to be "dreamers" for the purpose of the analyses, whether or not they could remember the narrative of the dream. However, only dreaming reports where the narrative was remembered were classified using five-point Likert scales as follows Emotional content (1 very negative; 5 very positive) ● Memorability (1 can't remember narrative of dream; 5 most memorable ever) ● Visual vividness (1 not at all vivid; 5 most vivid ever) ● Amount of sound (1 no sound; 5 most sound ever)

  at the end of surgery

Secondary Outcomes (1)

• Postoperative adverse effects

  24 hours after surgery

Study Arms (2)

BIS 40-50 Group

EXPERIMENTAL

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

Device: deep anesthesia depth

BIS 50-60 Group

EXPERIMENTAL

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.

Device: light anesthesia depth

Interventions

deep anesthesia depth 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 40-50 Group

light anesthesia depth 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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shengjing Hospital: lead

Study Sites (1)

Shengjing Hospital

Shenyang, Liaoning, 110004, China

RECRUITING

Study Officials

• junchao zhu

  Shengjing Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

junchao zhu

CONTACT

+8618940257257; zhujunchao1@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: November 25, 2021
• First Posted: May 3, 2022
• Study Start: December 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: July 31, 2022
• Last Updated: May 3, 2022

Record last verified: 2022-04

Locations

CN (1)