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Clinical Trials/CTRI/2024/04/066052
CTRI/2024/04/066052
Not yet recruiting
Not Applicable

Effect of preoperative quality of sleep on postoperative recovery and pain in patients undergoing elective neurosurgery for supratentorial lesions – a prospective observational study.

NIMHANS1 site in 1 country235 target enrollmentStarted: April 30, 2024Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
NIMHANS
Enrollment
235
Locations
1
Primary Endpoint
To study the impact of acute and chronic sleep disturbances on post-operative pain in neurosurgical patients

Overview

Brief Summary

This study is an open label prospective observational study aimed to study the effect of preoperative sleep quality in patinets of brain tumors undergoing elective neurosurgical procedures on post operative recovery outcomes like postoperative delirium and post operative pain relief along with post operative sleep quality thus, affecting recovery profile

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Conscious, alert and oriented patients at the time of assessment undergoing elective neurosurgery for supratentorial lesions.

Exclusion Criteria

  • Refusal of consent.
  • Patients with hearing difficulty, delirious, or with psychiatric disturbances.
  • Patients planned for post-operative mechanical ventilation.

Outcomes

Primary Outcomes

To study the impact of acute and chronic sleep disturbances on post-operative pain in neurosurgical patients

Time Frame: At end of surgery after extubation | at 24 hours post surgery | at 48 hours post surgery

To study the impact of acute and chronic sleep disturbances on post-operative delirium

Time Frame: At end of surgery after extubation | at 24 hours post surgery | at 48 hours post surgery

Secondary Outcomes

  • To study the impact of pre-operative cognition and anxiety on recovery outcome of patients.(To study the quality of sleep 30 days post surgery)

Investigators

Sponsor
NIMHANS
Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Dr Stuti Bhamri

National Institute of Mental Health and Neurosciences

Study Sites (1)

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