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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] 286941 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative Residual Block 295370 0
Condition category
Condition code
Anaesthesiology 295635 295635 0 0
Anaesthetics
Anaesthesiology 295780 295780 0 0
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] 292161 0
Treatment: Drugs
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295369 0
The PORC incidence with TOF Watch monitorization
Timepoint [1] 295369 0
For one hour in the recovery room
Primary outcome [2] 295485 0
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] 295485 0
For one hour in the recovery room
Secondary outcome [1] 315441 0
The onset time of neuromuscular blocking agent assessed by e TOF Watch
Timepoint [1] 315441 0
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
Gender
Both males and females
Can healthy volunteers participate?
No
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6993 0
Turkey
State/province [1] 6993 0
Bursa

Funding & Sponsors
Funding source category [1] 291514 0
Self funded/Unfunded
Name [1] 291514 0
Emine Yazar
Address [1] 291514 0
Sirnak Goverment Hospital,
Dicle neighborhood/ Cizre Street/ Bahcelievler/ 73000/ Sirnak
Country [1] 291514 0
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] 290195 0
None
Name [1] 290195 0
Address [1] 290195 0
Country [1] 290195 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293057 0
Sevket Yilmaz Training and Education Hospital Clinical Research Ethics Committee
Ethics committee address [1] 293057 0
Sevket Yilmaz Training and Education Hospital
Mimar Sinan Neighborhood/ Emniyet Street/ 16310 Yildirim/Bursa
Ethics committee country [1] 293057 0
Turkey
Date submitted for ethics approval [1] 293057 0
14/05/2012
Approval date [1] 293057 0
23/05/2012
Ethics approval number [1] 293057 0
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] 510 510 0 0

Contacts
Principal investigator
Name 58198 0
Dr Emine Yazar
Address 58198 0
Sirnak Goverment Hospital Clinic of Anesthesiology and Reanimation
Dicle Neighborhood, Cizre Street, Bahcelievler, 73000 Sirnak
Country 58198 0
Turkey
Phone 58198 0
+90,505,2689998
Fax 58198 0
Email 58198 0
e.yzr@hotmail.com
Contact person for public queries
Name 58199 0
Dr Derya Karasu
Address 58199 0
Bursa Sevket Yilmaz Training and Education Hospital Clinic of Anesthesiology and Reanimation
Mimar Sinan Neighborhood/ Emniyet Street/ 16310 Yildirim/Bursa
Country 58199 0
Turkey
Phone 58199 0
+90,505,7281175
Fax 58199 0
Email 58199 0
drderyatopuz@gmail.com
Contact person for scientific queries
Name 58200 0
Dr Canan Yilmaz
Address 58200 0
Bursa Sevket Yilmaz Training and Education Hospital Clinic of Anesthesiology and Reanimation
Mimar Sinan Neighborhood/ Emniyet Street/ 16310 Yildirim/Bursa
Country 58200 0
Turkey
Phone 58200 0
+90,505,9045989
Fax 58200 0
Email 58200 0
dr_cnnylmz@yahoo.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary