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Impact of Sleep Quality on Outcomes After Cardiac Surgery

A

Amrita Institute of Medical Sciences & Research Center

Status

Enrolling

Conditions

Delirium, Postoperative
Atrial Fibrillation
Complications, Postoperative
Sleep

Treatments

Device: Eye masks and ear plugs

Study type

Interventional

Funder types

Other

Identifiers

NCT06527105
IEC-AIMS-2023-CARDANES-009

Details and patient eligibility

About

Sleep is a basic human need and is essential for good quality of life, good health. In fact, humans spend one third of their life time in sleeping or attempting to do so. However, sleep is not given due importance in intensive care unit (ICU)'s, although it is critical in healing process. Patient's usually get admitted to the hospital few days prior to the surgery, for complete evaluation, depending on the procedure planned. Hospital environment being, an entirely new place for inpatients, will invariably affect their sleep. Sleep deprivation is one of the major sources of anxiety and stress in all the patients during ICU stay. This means that most of patients are sleep deprived, by the time they are admitted to ICU.

The negative effects of sleep deprivation include postoperative brain dysfunction like inattention, restlessness, hallucinations, agitation, aggressiveness. The degree of cognitive impairment may range from subtle derangements in attention, reason, clarity of thought and capacity of decision making to confusion and delirium. Sleep deprivation can also induce hypertension, fatigue, metabolic disorders, cerebrovascular and cardiovascular disease

Enrollment

100 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Adult cardiac surgical patients aged above 18years undergoing elective cardiac surgery

Exclusion criteria

  • Not willing to give consent
  • Preoperative sleep medications use
  • Preoperative psychological disorders, on mechanical ventilation for >12hrs, dementia, cerebrovascular accident

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

100 participants in 2 patient groups

Interventional group
Active Comparator group
Description:
Eye masks and Ear plugs given during sleep
Treatment:
Device: Eye masks and ear plugs
Control group
No Intervention group
Description:
Routine care given without any intervention

Trial contacts and locations

1

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Central trial contact

Nagarjuna P, MD, DM; Nagarjuna P

Data sourced from clinicaltrials.gov

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