Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12615000675527
Ethics application status
Approved
Date submitted
9/06/2015
Date registered
29/06/2015
Date last updated
29/06/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prospective study investigating relation between preoperative quality of sleep with anesthetic requirements
Scientific title
comparing anesthetic drugs requirements in preoperative poor quality sleepers versus good quality sleepers undergoing elective surgery
Secondary ID [1] 286871 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
preoperative sleep quality 295272 0
Condition category
Condition code
Anaesthesiology 295523 295523 0 0
Anaesthetics

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
evaluation of preoperative sleep quality using sleep electroencephalogram EEG for 8 hours on the night before surgery, recording induction dose of propofol needed to achieve bispectral index BIS value 40-60, recording intraoperative isoflurane requirements needed to achieve BIS 40-60 every 3 minutes
Intervention code [1] 292050 0
Not applicable
Comparator / control treatment
Comparing intraoperative anesthetic requirements in good sleepers versus bad sleepers. Patients are classified according to EEG findings as follows:
1.Total sleep time:good sleepers 6-8 hours, bad sleepers less than 3 hours
2. Slow wave sleep %: good sleepers 25-30%, bad sleepers less than 12%
3. Rapid eye movement sleep %: good sleepers 20-25%, bad sleepers less than 10%
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295260 0
Preoperative sleep quality using preoperative sleep EEG
Timepoint [1] 295260 0
The night before surgery for 8 hours interval
Primary outcome [2] 295261 0
Induction dose of propofol mg/kg needed to achieve BIS value 40-60
Timepoint [2] 295261 0
Induction of anesthesia
Primary outcome [3] 295262 0
Recording intraoperative isoflurane inspired concentration needed to achieve BIS index 40-60 every 3 minutes. Intraoperative isoflurane concentration will be measured using anesthetic gas analyzer attached to ventilator breathing circuits.
Timepoint [3] 295262 0
Baseline and every 3 minutes till the end of surgery
Secondary outcome [1] 315207 0
Intraoperative hemodynamics:
Non invasive blood pressure measured by automated cuff
Heart rate measured by intraoperative ECG
Timepoint [1] 315207 0
Baseline and then every 10 minutes till the end of surgery
Secondary outcome [2] 315218 0
Postoperative pain and analgesic requirements. This is a composite outcome
Timepoint [2] 315218 0
VAS score at the end of surgery then every 4 hours till 24 hours postoperative. Pethidine 1 mg/kg will be given if VAS more than or equal 4. Total pethidine requirements will be calculated for each patient.

Eligibility
Key inclusion criteria
ASA physical status 1 and 2, Body mass index BMI 25-30, Normal sleep wake pattern, Patient with Epworth sleepiness scale scores less than 5, patients scheduled for elective open cholecystectomy, open upper abdominal hernia mesh repair, male patients only due to cultural obstacles to sleep EEG measurements.
Minimum age
20 Years
Maximum age
40 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
History of sleep disorders e.g. insomnia, Addiction, History of intake of any drug that affects sleep cognition e.g. antidepressants.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2012
Actual
1/06/2012
Date of last participant enrolment
Anticipated
1/01/2013
Actual
1/01/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
27
Accrual to date
Final
Recruitment outside Australia
Country [1] 6960 0
Egypt
State/province [1] 6960 0
giza

Funding & Sponsors
Funding source category [1] 291431 0
Hospital
Name [1] 291431 0
Theodor Bilharz Research Institute
Country [1] 291431 0
Egypt
Primary sponsor type
Hospital
Name
Theodor Bilharz Research Institute
Address
El-Nile St., Warrak El-Hader, Imbaba Giza
Country
Egypt
Secondary sponsor category [1] 290107 0
Government body
Name [1] 290107 0
Academy of Scientific Research and Technology
Address [1] 290107 0
101 Al Qasr Al Aini st
Cairo
Country [1] 290107 0
Egypt

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Sleep disturbances are common among surgical patients in the preoperative period due to anxiety. Since general anesthesia and physiological sleep share many similarities, the aim of this study is to examine the relation between preoperative quality of sleep and intraoperative anesthetic requirements and postoperative analgesic requirements.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 494 494 0 0
/AnzctrAttachments/368710-Ethical committe approval.pdf

Contacts
Principal investigator
Name 57898 0
Dr Mohamed Ahmed Maher
Address 57898 0
Lecturer of Anesthesia in Theodor Bilharz Research Institute(TBRI).
El-Nile St., Warrak El-Hader, Imbaba Giza , Egypt P.O.BOX : 30 Imbaba
Country 57898 0
Egypt
Phone 57898 0
+(202)35401019
Fax 57898 0
Email 57898 0
[email protected]
Contact person for public queries
Name 57899 0
Mohamed Ahmed Maher
Address 57899 0
Lecturer of Anesthesia in Theodor Bilharz Research Institute(TBRI).
El-Nile St., Warrak El-Hader, Imbaba Giza , Egypt P.O.BOX : 30 Imbaba
Country 57899 0
Egypt
Phone 57899 0
+(202)35401019
Fax 57899 0
Email 57899 0
[email protected]
Contact person for scientific queries
Name 57900 0
Mohamed Ahmed Maher
Address 57900 0
Lecturer of Anesthesia in Theodor Bilharz Research Institute(TBRI).
El-Nile St., Warrak El-Hader, Imbaba Giza , Egypt P.O.BOX : 30 Imbaba
Country 57900 0
Egypt
Phone 57900 0
+(202)35401019
Fax 57900 0
Email 57900 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.