ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12617001042336

Ethics application status

Approved

Date submitted

29/05/2017

Date registered

17/07/2017

Date last updated

17/07/2017

Type of registration

Retrospectively registered

Titles & IDs

Public title

The effect of anesthesia type on intraocular pressure for lumbar surgery operations.

Scientific title

The effect of spinal and general anesthesia on intraocular pressure for lumbar discectomy surgery

Secondary ID [1]

Nil Known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

patients who have herniated lomber disc

Condition category

Condition code

Anaesthesiology

Anaesthetics

Musculoskeletal

Other muscular and skeletal disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Patients divided two groups. Anesthesia types are differnt for groups.
1. Group: Spinal anesthesia with 15 mg bupivacaine ( given to cerebrospinal fluid) before procedure.
2. Group General anesthesia with 2 mcg/kg fentanyl intravenous.,, 2 mg/kg propofol intravenous.and 0.6 mg / kg rocuronium intravenous induction doses, and anesthesia maintenance with 2 % sevoflurane inhalation until completion of procedure.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Comparing spinal and general anesthesia

Control group

Active

Outcomes

Primary outcome [1]

intraocular pressure measurements with portable tonometer (for intraocular pressure measurement)

Timepoint [1]

preoperative time ( basal ) , 10 minutes after anesthesia application, 10 minutes after prone positioning, at the end of the operation are four timepoints for intraocular pressure measurements.

Secondary outcome [1]

visual disturbance after operation

Timepoint [1]

1. day after surgery with asking patients verbally

Eligibility

Key inclusion criteria

1) Patients > 18 years old
2) Patients who undergo lumbar discectomy surgery
3) ASA I-III physical status patients

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1) Patients who have any eye illness
2) Any operation from eyes
3) Beta blocker drug usage
4) Known local anesthetic allergy

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

Actual

1/03/2017

Date of last participant enrolment

Anticipated

30/08/2017

Actual

Date of last data collection

Anticipated

31/08/2017

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Turkey

State/province [1]

KONYA

Funding & Sponsors

Funding source category [1]

University

Name [1]

Baskent University

Address [1]

Taskent Caddesi (Eski 1. Cadde) 77. Sokak (Eski 16. Sokak) No:11 06490 Bahcelievler / ANKARA

Country [1]

Turkey

Primary sponsor type

University

Name

Baskent University

Address

Taskent Caddesi (Eski 1. Cadde) 77. Sokak (Eski 16. Sokak) No:11 06490 Bahcelievler / ANKARA

Country

Turkey

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Baskent University Clinical Research Ethical Committee

Ethics committee address [1]

Taskent Caddesi 77. Sokak No:11 06490 Bahcelievler Cankaya Ankara

Ethics committee country [1]

Turkey

Date submitted for ethics approval [1]

11/04/2013

Approval date [1]

12/11/2013

Ethics approval number [1]

KA 13/103

Summary

Brief summary

Prone position can increase intraocuar pressure especially for lumbar surgery. Many studies evaluated intraocular pressure in patients under general anesthesia. But there is not a study examinig patient under spinal anesthesia. In this study our aim is to investigate effects of spinal and general anesthesia on lumbar discectomy patients in prone position.
40 ASA I-III patients over 18 years old who undergo lumbar disc surgery patients will paritcipate study. Eye illness, eye surgery history, beta blocker drug usage, local anesthetic allergy are exclusion criterias. we record heigt, weight, hypertension or diabetes mellitus existence.
We randomize patients in two groups. 1) Spinal anesthesia group 2) General anesthesia group
We both measure intraocular pressure of both eyes each group when patients are supin position with portable tonometer. After that, we will perform spinal anesthesia with 15 mg hiperbaric bupivacaine from L3-4 lumbar interspace for spinal group and general anesthesia induction with fentanyl 2mcg/kg i.v., propofol 2 mg /kg i.v. and rocuronium 0.6 mg/kg for general anesthesia group patients and maintain anesthesia with 2% sevoflurane  i.v.. We measure intraocular pressure after anesthesia at 10th minute, 10 minutes after prone positioning and at the end of the operation at prone position. We will record mean arterial pressure, at intraocular pressure measurements time, We will ask patients at  first postoperative day if they have any visual disturbances.
We compare the results of intraocular pressures and evaluate with appropriate statistical methods.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Mr Huseyin Ulas Pinar

Address

Hocacihan mah. saray cad No:1 Selcuklu/ Konya postal Code: 42080

Country

Turkey

Phone

+903322570606

Fax

huseyinpinar2@gmail.com

Contact person for public queries

Name

Huseyin Ulas Pinar

Address

Hocacihan mah. saray cad No:1 Selcuklu/ Konya Postal Code: 42080

Country

Turkey

Phone

+903322570606

Fax

huseyinpinar2@gmail.com

Contact person for scientific queries

Name

Huseyin Ulas Pinar

Address

Hocacihan mah. saray cad No:1 Selcuklu/ Konya
Postal Code : 42080

Country

Turkey

Phone

+903322570606

Fax

huseyinpinar2@gmail.com

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

Source	Title	Year of Publication	DOI
Embase	The effect of spinal versus general anesthesia on intraocular pressure in lumbar disc surgery in the prone position: A randomized, controlled clinical trial.	2018	https://dx.doi.org/10.1016/j.jclinane.2018.01.026

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically