ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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

ACTRN12615000758505

Ethics application status

Approved

Date submitted

22/06/2015

Date registered

21/07/2015

Date last updated

21/07/2015

Type of registration

Retrospectively registered

Titles & IDs

Public title

A Comparision of the Effect of Sugammadex on the Recovery Period and Postoperative Residual Block in Young Elderly (65-74) and Middle-Old Elderly (>74) Patients

Scientific title

A Comparision of the Effect of Sugammadex on the Recovery Period and Postoperative Residual Block in two groups of elderly patients undergoing laparoscopic cholecystectomy

Secondary ID [1]

none

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Postoperative Residual Block

Condition category

Condition code

Anaesthesiology

Anaesthetics

Anaesthesiology

Other anaesthesiology

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Sixty patients over the age of 65 with ASA I-III were divided into two groups according to their age (65-74 years old and greater than 74 years old). Patients received sugammadex (2.0 mg/kg intravenous) at the reappearance of the second twitch of the train of four (TOF) Watch as an agent for reversal of neuromuscular blockage at the end of surgery. Patients were extubated at the time of TOF equal 0.9. The patients’ TOF responses were evaluated with regards to postoperative residual curarization (PORC) in fifth minute and were followed up for one hour in the recovery room. Reintubation was applied for those patients who developed PORC and had SpO2 less than 90% despite being given 6L oxygen per min with a face mask

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

no control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

The PORC incidence with TOF Watch monitorization

Timepoint [1]

For one hour in the recovery room

Primary outcome [2]

Rate of reintubation
Patients whose SpO2 value could not be kept over 90 % despite the administration of 6 L/min oxygen were reintubated.

Timepoint [2]

For one hour in the recovery room

Secondary outcome [1]

The onset time of neuromuscular blocking agent assessed by e TOF Watch

Timepoint [1]

until the patient's extubation

Eligibility

Key inclusion criteria

-over the age of 65
-whom laparoscopic chloecystectomy was planned
-ASA I-III

Minimum age

65 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

-Patients with renal and hepatic failure
-Patients with musculoskeletal disease
-Family history of malignant hyperthermia
-BMI over 30

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised 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

Phase 4

Type of endpoint/s

Statistical methods / analysis

Statistical analysis of the study was carried out using Statistical Package 21.0 for Windows (SPSS Inc., Armonk, NY, USA). Shapiro-Wilk test was used as normallity test. Continuous variables were compared using Mann-Whitney U test when the data were not normally distributed. Wilcoxon Signed rank test was used for dependent groups. Categorical variables were compared using Pearson’s chi-squared test and Fisher’s exact test. Correlations between variables were tested using Spearman correlation coefficient. Results were given as median (min-max) values. The p value of <0.05 was considered statistically significant and the values were expressed as ''median-minimum-maximum'' or as a number. The power calculation for the present study was calculated according to the T0.9 and an alpha level set at 0.05. The power was calculated as 0.64 according to recorded sample size.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

24/05/2012

Actual

24/05/2012

Date of last participant enrolment

Anticipated

31/12/2012

Actual

31/12/2012

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Turkey

State/province [1]

Bursa

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Emine Yazar

Address [1]

Sirnak Goverment Hospital,
Dicle neighborhood/ Cizre Street/ Bahcelievler/ 73000/ Sirnak

Country [1]

Turkey

Primary sponsor type

Individual

Name

Emine Yazar

Address

Sirnak Goverment Hospital,
Dicle neighborhood/ Cizre Street/ Bahcelievler/ 73000/ Sirnak

Country

Turkey

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sevket Yilmaz Training and Education Hospital Clinical Research Ethics Committee

Ethics committee address [1]

Sevket Yilmaz Training and Education Hospital  
Mimar Sinan Neighborhood/ Emniyet Street/ 16310 Yildirim/Bursa

Ethics committee country [1]

Turkey

Date submitted for ethics approval [1]

14/05/2012

Approval date [1]

23/05/2012

Ethics approval number [1]

2012/10/3

Summary

Brief summary

Background: The importance of the characteristics of anesthesia and postoperative residual curarization (PORC) in the elderly population should be a growing concern in this century.
Aims: To investigate the effect of sugammadex on the duration of the recovery from neuromuscular blocking agents and postoperative residual curarization in the young elderly and middle-old elderly patients who underwent elective laparoscopic cholecystectomy, followed by a train of four (TOF) Watch monitorization. 
Methods: Sixty patients over the age of 65 with ASA I-III were divided into two groups according to their age (65-74 years old and older than 74 years ). Patients received sugammadex (2.0 mg/kg iv) at the reappearance of the second twitch of the TOF as an agent for reversal of neuromuscular blockage at the end of surgery.  Patients were extubated at the time of TOF  equal to 0.9 value. The patients’ TOF responses were evaluated with regards to PORC in at the fifth minute and were followed up for one hour in the recovery room. Reintubation was applied for those patients who developed PORC and had SpO2 less than 90% despite being given 6L oxygen per min with a face mask 
Results: The onset time of neuromuscular blocking agent and time from T2 to achieve TOF ratio 90% or over were found to be longer in the middle-old elderly group than in the young elderly group. A statistically significant relationship was found between age and the duration of TOF ratio to reach 0.9 in the same direction. The PORC incidence and rate of reintubation were found to be  1.7% in all patients. 
Conclusions: In our opinion, it is necessary to remember that the onset of the sugammadex effect is prolonged for patients who are aged older than 74 years compared to patients aged between 65-74 years.

Trial website

Trial related presentations / publications

Public notes

Attachments [1]

/AnzctrAttachments/368785-etic.pdf

Contacts

Principal investigator

Name

Dr Emine Yazar

Address

Sirnak Goverment Hospital Clinic of Anesthesiology and Reanimation
Dicle Neighborhood, Cizre Street, Bahcelievler, 73000 Sirnak

Country

Turkey

Phone

+90,505,2689998

Fax

e.yzr@hotmail.com

Contact person for public queries

Name

Derya Karasu

Address

Bursa Sevket Yilmaz Training and Education Hospital Clinic of Anesthesiology and Reanimation
Mimar Sinan Neighborhood/ Emniyet Street/ 16310 Yildirim/Bursa

Country

Turkey

Phone

+90,505,7281175

Fax

drderyatopuz@gmail.com

Contact person for scientific queries

Name

Canan Yilmaz

Address

Bursa Sevket Yilmaz Training and Education Hospital Clinic of Anesthesiology and Reanimation
Mimar Sinan Neighborhood/ Emniyet Street/ 16310 Yildirim/Bursa

Country

Turkey

Phone

+90,505,9045989

Fax

dr_cnnylmz@yahoo.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	A comparision of the effect of sugammadex on the recovery period and postoperative residual block in young elderly and middle-aged elderly patients.	2016	https://dx.doi.org/10.5152/balkanmedj.2016.16383

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

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically