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Trial record 2 of 4 for:    19535947 [PUBMED-IDS]

Effect of Standard Normothermia Protocol On Surgical Site Infections

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ClinicalTrials.gov Identifier: NCT02961244
Recruitment Status : Completed
First Posted : November 10, 2016
Results First Posted : May 11, 2017
Last Update Posted : December 12, 2017
Sponsor:
Information provided by (Responsible Party):
Ali Kadir Değirmenci, Dokuz Eylul University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Condition: Surgical Site Infection
Interventions: Other: Prewarming and perioperative warming with Forced Air Warming device and its blankets.
Device: Forced Air Warming blanket

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between June 2013 and December 2015 elective, preoperatively not infected/dirty, open major abdominal operations under general anesthesia, longer than 30 minutes and over 18 aged were included in the study. Primary outcome was comparison of SSI rates between groups and secondary was effects of protocol to normothermia.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Exclusion criteria were emergent surgery, local/locoregional procedures, laparoscopic operations, minor abdominal operations, malign hyperthermia, signs of active infection/fever, immunosuppression, malnutrition, kidney/liver failure, antibiotic use within the previous 1 week/ımmunsupresive use within previous 1 month, reversal of approval.

Reporting Groups
  Description
Control Group Perioperative management and warming was not performed according to a standard normothermia protocol, with our clinic's traditional methods except prewarming.
Intervention Group

Perioperative management and warming was performed according to a standard normothermia protocol with active prewarming.

Prewarming and perioperative warming with Forced Air Warming device and its blankets.

Forced Air Warming blanket


Participant Flow:   Overall Study
    Control Group   Intervention Group
STARTED   64   64 
Patients Excluded During Randomization   0   1 
COMPLETED   63   55 
NOT COMPLETED   1   9 
Protocol Violation                0                1 
Withdrawal by Subject                1                2 
Surgery plan change after study approval                0                2 
Lost to Follow-up                0                2 
İnadequate data                0                2 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Control Group Perioperative management and warming was not performed according to a standard normothermia protocol, with our clinic's traditional methods except prewarming.
Intervention Group

Perioperative management and warming was performed according to a standard normothermia protocol with active prewarming.

Prewarming and perioperative warming with Forced Air Warming device and its blankets.

Forced Air Warming blanket

Total Total of all reporting groups

Baseline Measures
   Control Group   Intervention Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 63   55   118 
Overall Units Analyzed (Patients) 
[Units: Patients]
 63   55   118 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
     
Participants Analyzed   63   55   118 
Age   58.0  (14.3)   57.6  (12.9)   57.8  (13.6) 
[1] For age variable, groups were homogeneous. (p=0.870)
Sex: Female, Male [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed   63   55   118 
Sex: Female, Male       
Female      34  54.0%      23  41.8%      57  48.3% 
Male      29  46.0%      32  58.2%      61  51.7% 
[1] For gender variable, groups were homogeneous. (p=0.190)
BMI [1] 
[Units: Kilograms per square meter]
Mean (Standard Deviation)
     
Participants Analyzed   63   55   118 
BMI   26.6  (4.9)   26.8  (4.4)   26.7  (4.7) 
[1] For BMI variable, groups were homogeneous. (p=0.836)
Weight [1] 
[Units: Kilograms]
Mean (Standard Deviation)
     
Participants Analyzed   63   55   118 
Weight   72.8  (14.9)   75.3  (14.5)   74  (14.7) 
[1] For weight variable, groups were homogeneous. (p=0.346)
Height [1] 
[Units: Centimeters]
Mean (Standard Deviation)
     
Participants Analyzed   63   55   118 
Height   165.1  (8.6)   167.3  (8.7)   166.0  (8.0) 
[1] For height variable, groups were homogeneous. (p=0.166)
Ethiology [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed   63   55   118 
Ethiology       
Hepatopancreaticobiliary System Etiology      24  38.1%      10  18.2%      34  28.8% 
Colorectal Tract Etiology      32  50.8%      32  58.2%      64  54.2% 
Upper Gastointestinal Tract      7  11.1%      13  23.6%      20  16.9% 
[1] Etiologies including hepatopancreaticobiliary, colorectal, upper gastrointestinal systems diseases .
Smoking habit [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed   63   55   118 
Smoking habit       
Nonsmoker      30  47.6%      26  47.3%      56  47.5% 
Smoking History      33  52.4%      29  52.7%      62  52.5% 
[1] For smoking habit both groups were homogenous.(p=0.893)
Alcohol Use [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed   63   55   118 
Alcohol Use       
Alcohol use (<2 glass)      61  96.8%      52  94.5%      113  95.8% 
Alcohol use (≥2 glass)      2   3.2%      3   5.5%      5   4.2% 
[1] For alcohol use, groups were homogeneous. (p=0.541)
Type of anesthesia [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed   63   55   118 
Type of anesthesia       
General anesthesia      16  25.4%      15  27.3%      31  26.3% 
General and epidural anesthesia      29  46.0%      20  36.4%      49  41.5% 
General and intrathecal anesthesia      18  28.6%      20  36.4%      38  32.2% 
[1] For anesthesia choice, groups were homogeneous. (p=0.655)
Epidural catheter removal time if any inserted [1] [2] 
[Units: Days]
Mean (Standard Deviation)
     
Participants Analyzed   29   20   49 
Participants Analyzed   63   55   118 
Epidural catheter removal time if any inserted   5.07  (2.3)   5.09  (2)   5.08  (2.2) 
[1] For epidural catheher removal time, groups were homogeneous. (p=0.973)
[2] For patients only had had epidural catheter inserted.
Central venous access [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed   63   55   118 
Central venous access       
Not used      18  28.6%      21  38.2%      39  33.1% 
Used temporary methods      33  52.4%      20  36.4%      53  44.9% 
Permenant central venous port previously inserted      12  19.0%      14  25.5%      26  22.0% 
[1] For cetral venous access choice groups were homogeneous. (p=0.107)
If only temporary, removal time of central venous catheter [1] [2] 
[Units: Days]
Mean (Standard Deviation)
     
Participants Analyzed   33   20   53 
Participants Analyzed   63   55   118 
If only temporary, removal time of central venous catheter   6.09  (3.7)   7.2  (2.6)   6.5  (3.4) 
[1] For temporary central venous catheter removing time both groups were homogenous. (p=0.259)
[2] For patients only had had temporary central venous catheter inserted.
Operating Room Temperature [1] 
[Units: ºC degrees]
Mean (Standard Deviation)
     
Participants Analyzed   63   55   118 
Units Analyzed (Patients)   63   55   118 
Operating Room Temperature   21.3  (2)   21.5  (2)   21.4  (2) 
[1] For operating room temperature variable, groups were homogeneous. (p=0.059)
İntraoperative blood loss [1] 
[Units: Liters]
Mean (Standard Deviation)
     
Participants Analyzed   63   55   118 
İntraoperative blood loss   0.23  (0.3)   0.26  (0.36)   0.24  (0.33) 
[1] For intraoperative blood loss data, groups were homogeneous. (p=0.614)
İntraoperative red cell transfusion [1] 
[Units: Units]
Mean (Standard Deviation)
     
Participants Analyzed   63   55   118 
İntraoperative red cell transfusion   0.24  (0.58)   0.33  (0.74)   0.25  (0.6) 
[1] For intraoperative red cell transfusion variable, groups were homogeneous. (p=0.470)
Intraoperative fresh frozen plasma transfusion 
[Units: Units]
Mean (Standard Deviation)
     
Participants Analyzed   63   55   118 
Intraoperative fresh frozen plasma transfusion   0  (0)   0.018  (0.134)   0.008  (0.009) 
Intraoperative cristalloid fluid [1] 
[Units: Liters]
Mean (Standard Deviation)
     
Participants Analyzed   63   55   118 
Intraoperative cristalloid fluid   3.06  (1.38)   3.01  (1.4)   3.04  (1.38) 
[1] For cristalloid fluid infusement amounts, groups were homogeneous. (p=0.855)
Intraoperative colloid fluid [1] 
[Units: Liters]
Mean (Standard Deviation)
     
Participants Analyzed   63   55   118 
Intraoperative colloid fluid   0.42  (0.57)   0.33  (0.42)   0.38  (0.5) 
[1] For colloid fluid infusement amounts, groups were homogeneous. (p=0.361)
Intraoperative urine output [1] 
[Units: Liters]
Mean (Standard Deviation)
     
Participants Analyzed   63   55   118 
Intraoperative urine output   0.77  (0.71)   0.7  (0.57)   0.74  (0.64) 
[1] For peroperative urine output, groups were homogeneous. (p=0.559)
Mean heart rate [1] 
[Units: Beats per minute]
Mean (Standard Deviation)
     
Participants Analyzed   63   55   118 
Mean heart rate   78  (13.4)   75.8  (14.5)   77  (13.9) 
[1] For mean heart rate amounts, groups were homogeneous. (p=0.390)
Intraoperative mean arterial blood pressure [1] 
[Units: Mm Hg]
Mean (Standard Deviation)
     
Participants Analyzed   63   55   118 
Intraoperative mean arterial blood pressure   89.1  (13.2)   87  (7)   88.1  (13.4) 
[1] For intraoperative mean arterial blood pressure levels, groups were homogeneous. (p=0.388)
Operation duration [1] 
[Units: Minutes]
Mean (Standard Deviation)
     
Participants Analyzed   63   55   118 
Operation duration   239.6  (118.3)   199.9  (106.3)   221.1  (114) 
[1] For operation duration , groups were homogeneous. (p=0.059)
Perioperative hemoglobin levels [1] 
[Units: G/dl]
Mean (Standard Deviation)
     
Participants Analyzed   63   55   118 
Preoperative   11.81  (1.49)   11.8  (1.35)   11.81  (1.42) 
Postoperative 1. Day   11.0  (1.58)   11.19  (1.54)   11.09  (1.55) 
∆(Hemoglobin)   0.80  (1.22)   0.61  (1.10)   0.71  (1.16) 
[1] Preoperative (p=0.984), postoperative first day (p=0.526) and ∆(Hemoglobin)(the difference between preoperative and postoperative first day levels)(p=0.385)
Perioperative albumin levels [1] 
[Units: G/dl]
Mean (Standard Deviation)
     
Participants Analyzed   63   55   118 
Preoperative   3.74  (0.46)   3.66  (0.5)   3.71  (0.48) 
Postoperative 1. Day   2.86  (0.56)   2.96  (0.5)   2.91  (0.53) 
∆(Albumin)   0.88  (0.51)   0.69  (0.5)   0.79  (0.51) 
[1] Preoperative (p=0.359), postoperative first day (p=0.314) and ∆(Albumin)(the difference between preoperative and postoperative first day levels)(p=0.055)
Profilactic antibiotics [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed   63   55   118 
Cefazolin   30   22   52 
Cefuroxime + metronidazole   30   32   62 
Ceftriaxone   1   1   2 
Ceftriaxone+ metronidazole   1   0   1 
Amoxicillin + clavulanate   1   0   1 
[1] There were not enough numbers in all boxes so statistical analyses not appropriate to assess for this title.
Duration of Hospitalization Parameters [1] [2] 
[Units: Days]
Mean (Standard Deviation)
     
Total Duration of Hospitalization       
Participants Analyzed   63   55   118 
Total Duration of Hospitalization   18.96  (18.62)   19.4  (10.49)   19.25  (15.28) 
Preoperative Duration of Hospitalization       
Participants Analyzed   63   55   118 
Preoperative Duration of Hospitalization   6.87  (5.91)   7.47  (6.49)   7.15  (6.17) 
Postoperative Duration of Hospitalization       
Participants Analyzed   63   55   118 
Postoperative Duration of Hospitalization   12.09  (15.54)   12.1  (9.07)   12.1  (12.88) 
Duration of ICU Hospitalization       
Participants Analyzed   16   11   27 
Participants Analyzed   63   55   118 
Duration of ICU Hospitalization   3.5  (5.68)   3.45  (7.48)   3.48  (6.33) 
[1] Between two groups duration of hospitalizations were not statistically different including parameters of Total Duration of Hospitalization (p=0.879), Preoperative Duration of Hospitalization (p=0.601), Postoperative Duration of Hospitalization (0.995) and Duration of ICU Hospitalization (0.346).
[2] In our study 11 patients from intervention group and 16 patients from control group needed ICU follow up after surgery. (p=0.348)
Simple Hospitalization costs [1] 
[Units: Thousand Turkish liras]
Mean (Standard Deviation)
     
Participants Analyzed   63   55   118 
Simple Hospitalization costs   12.6  (9.8)   11.7  (6.1)   12.2  (8.3) 
[1] These data is not result of standardized (like in the literature suggests) costs data.These data made by our patients data system which can calculate goverments payments fees, etc for any procedure performed to any patient. (intervention based data ) (p=0.524)
Perioperative Warming [1] [2] 
[Units: Participants]
     
Peroperatuar Warming       
Participants Analyzed   63   55   118 
Peroperatuar Warming   63   55   118 
Postoperative Warming       
Participants Analyzed   13   55   68 
Participants Analyzed   63   55   118 
Postoperative Warming   13   47   60 
[1] There were not enough numbers in all boxes so statistical analyses not appropriate to assess for preoperative and peroperative warming. Postoperative warming choices were significiantly different between two groups as excepted because of study protocols contents.(p<0.001)
[2] Preoperative Warming which is not our center's traditional method for routine maintaining normothermia procedures, performed for only and to all of intervention group patients . For this reason it is not inculed to this analyze table.
Surgical Site Classification [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed   63   55   118 
Clean   4   2   6 
Clean-Contaminated   58   52   110 
Contaminated   1   1   2 
[1]

During the preoperative patient's approval period, if surgical site is predicted as contaminated and dirty, these patients not appropriate for study. (preoperatively) In 2 patients preoperatively appropriate was found that peroperatively they had closed microperforation of tumor.Though minimal contamination detected perioperatively and there were not any clinical findings of infection, they accepted as contaminated.

There were not enough numbers in all boxes so statistical analyses not appropriate to assess.

ASA Score [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed   63   55   118 
ASA Score       
ASA 1      22  34.9%      19  34.5%      41  34.7% 
ASA 2      32  50.8%      29  52.7%      61  51.7% 
ASA 3      9  14.3%      7  12.7%      16  13.6% 
[1] For ASA scores groups were homogeneous. (p=0.943) ASA 4,5,6 is not shown because of the study inclusion criterias. (ASA which has known as American Society of Anesthesiologists Physical Status, min. 1 and max. 6). Definitions: ASA 1-Normal healthy patients, ASA 2-A patient with mild systemic disease. ASA 3-A Patient with severe systemic disease, ASA4-A patient with severe systemic disease that is a constant threat to life, ASA5-A moribund patient who is not expected to survive without the operation, ASA6-A declared brain-dead patient whose organs are being removed for donor purposes)
NNISS Score [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed   63   55   118 
<2   52   46   98 
≥2   11   9   20 
[1] For NNISS scores groups were homogeneous. (p=0.875) NNISS Score which has known as The National Nosocomial Infections Surveillance System Scoring System used for prediction of the risk of Surgical Site İnfections (SSI).The NNIS basic SSI risk index is composed of the following criteria: American Society of Anesthesiologists score of 3, 4, or 5 (>2 takes one score; wound class( contaminated or dirty takes one point; and duration of surgery (There are percantile times defined and above 75 percantile, score takes one point) NNISS Score may be 0 to 3, and SSI risks were increased by score.
SENIC Score [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed   63   55   118 
<3   57   48   105 
≥3   6   7   13 
[1]

For SENIC scores groups were homogeneous. (0.581) This Scoring system has known as Study on Efficacy of Nosocomial Infection Control (SENIC) project's SSI Risk Scoring System (Min. 0 to max. 4 points may be calculated , risk of SSI incerases by score ). 4 criterias include duration of surgery (>2 hours), abdominal surgery, wound class( contaminated or dirty takes one point) and comorbidities (>2) which is any of them is one points.

Because of the participants who in each score (0-4) was not enough to analyse statisticaly, participants divided into two groups. (<3 and ≥3)

Comorbidities [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed   63   55   118 
Congestive Heart Failure   1   2   3 
Pulmonary Circulation Disorders   0   5   5 
Complicated Hypertension   2   4   6 
Uncomplicated Hypertension   19   19   38 
Chronic Respiratory Diseases   2   4   6 
Uncomplicated Diabetes   11   10   21 
Complicated Diabetes   0   3   3 
Hypothyroidism   8   3   11 
Lymphoma   1   1   2 
Metastatic Cancer   16   11   27 
Non-metastatic Solid Tumor   45   43   88 
Other(Valvuler, collagen tissue, etc diseases)   4   1   5 
[1] There were not enough numbers in all boxes so statistical analyses not appropriate to assess for this title. Buy for classifaciton of the comobidities, Elixhauser Classification used for standart data presentation.
Perioperative Temperature Measurements [1] [2] 
[Units: ºC degrees]
Mean (Standard Deviation)
     
Perioperative Minimum Measurement       
Participants Analyzed   63   55   118 
Perioperative Minimum Measurement   35.17  (0.59)   35.76  (0.52)   35.44  (0.63) 
Preoperative Room Enterance Temperature       
Participants Analyzed   63   55   118 
Preoperative Room Enterance Temperature   36.94  (0.47)   36.94  (0.46)   36.94  (0.46) 
Preoperative Room Exit Temperature       
Participants Analyzed   63   55   118 
Preoperative Room Exit Temperature   37.03  (0.4)   36.89  (0.5)   36.96  (0.46) 
After Entubation Temperature       
Participants Analyzed   63   55   118 
After Entubation Temperature   36.36  (0.6)   36.66  (0.46)   36.5  (0.56) 
Postentubation 60. minutes Temperature       
Participants Analyzed   63   55   118 
Postentubation 60. minutes Temperature   35.74  (0.62)   36.16  (0.56)   35.9  (0.62) 
Postentubation 120. minutes Temperature       
Participants Analyzed   63   55   118 
Postentubation 120. minutes Temperature   35.8  (0.73)   36.28  (0.6)   35.9  (0.76) 
Postentubation 180. minutes Temperature       
Participants Analyzed   63   55   118 
Postentubation 180. minutes Temperature   35.63  (0.86)   36.25  (0.72)   35.88  (0.86) 
Postentubation 240. minutes Temperature       
Participants Analyzed   63   55   118 
Postentubation 240. minutes Temperature   35.5  (0.82)   36.45  (0.87)   35.85  (0.95) 
After Extubation Temperature       
Participants Analyzed   63   55   118 
After Extubation Temperature   35.88  (0.74)   36.54  (0.67)   36.21  (0.77) 
Recovery Room Enterance Temperature       
Participants Analyzed   63   55   118 
Recovery Room Enterance Temperature   35.84  (0.75)   36.41  (0.64)   36.12  (0.75) 
Recovery Room ExitTemperature       
Participants Analyzed   63   55   118 
Recovery Room ExitTemperature   36.48  (0.62)   36.7  (0.61)   36.59  (0.62) 
Service Enterance Temperature       
Participants Analyzed   47   44   91 
Participants Analyzed   63   55   118 
Service Enterance Temperature   36.31  (0.42)   36.35  (0.38)   36.33  (0.4) 
ICU Enterance Temperature (ICU patients)       
Participants Analyzed   16   11   27 
Participants Analyzed   63   55   118 
ICU Enterance Temperature (ICU patients)   35.78  (0.95)   36.08  (0.64)   35.89  (0.85) 
[1] Perioperative Minimum Measurement p<0.001 Preoperative Room Enterance Temperature p=0.980 Preoperative Room Exit Temperature p=0.094 After Entubation Temperature p=0.011 Postentubation 60. minutes Temperature p<0.001 Postentubation 120. minutes Temperature p<0.001 Postentubation 180. minutes Temperature p=0.001 Postentubation 240. minutes Temperature p=0.001 After Extubation Temperature p<0.001 Recovery Room Enterance Temperature p<0.001 Recovery Room ExitTemperature p=0.094 Service Enterance Temperature p=0.716
[2]

In our study 11 patients from intervention group and 16 patients from control group needed ICU follow-up after surgery. For this reason ICU patient's measurements were not including service data.

Also these measurements were not including 300, 360, 420, 480, 540, 600 minutes data.Because most of the patients operation times are less than 6 hours.

Infectious Complications [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed   63   55   118 
No İnfectious Complications   42   43   85 
Pulmonary   4   1   5 
Urinary   2   2   4 
Bacteriemia   3   1   4 
SSI   18   9   27 
[1] Our study's main outcome which is SSI is significiantly different between two groups.(p=0.044)
SSI Classification 
[Units: Participants]
Count of Participants
     
Participants Analyzed   63   55   118 
Superficial Incisional   10   6   16 
Deep Incisional   3   1   4 
Organ-Space   5   2   7 
ASEPSIS Total Scores [1] 
[Units: Points]
Mean (Standard Deviation)
     
Participants Analyzed   63   55   118 
ASEPSIS Total Scores   17.83  (13.83)   12.64  (10.6)   15.41  (12.67) 
[1] ASEPSIS Wound Scoring System used in our study. ASEPSIS postoperative total Points (p=0.029) was different between two groups. Simply points are given for the need for Additional treatment, the presence of Serous discharge, Erythema, Purulent exudate, and Separation of the deep tissues, the Isolation of bacteria, and the duration of inpatient Stay (ASEPSIS). (min. is 0 points and max. doesn't have any limit but 0-10 points is succesful, 11-20 points is impaired healing and 21-30 points is mild, 31-40 is moderate, >41 points is severe SSI.)


  Outcome Measures

1.  Primary:   Surgical Site Infection Rate   [ Time Frame: Postoperative 30 days ]

2.  Secondary:   Maintaining Normothermia Rate   [ Time Frame: Surgery day ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Surgical etiologies were various.It was a single-centered trial whose power was 80%.The room temperatures could not be kept constant.The number of samples were not enough to make variate analysis of SSI and hypothermia risk factors.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Ali Kadir Degirmenci
Organization: Dokuz Eylul University Medicine Faculty, General Surgery Department
phone: +902324122901
e-mail: alikadir@hotmail.com


Publications:
Sessler DI. Perioperative thermoregulation. Geriatr Anesthesiol. 2008;6736(15):107-22
Clinical practice guideline: The management of inadvertent perioperative hypothermia in adults National Collaborating Centre for Nursing and Supportive Care commissioned by National Institute for Health and Clinical Excellence. 2008;88-92, 204-445
Arslan NC, Terzi C, Kaya Ozlem, et. al. Perioperative Body Temperature: One Day Prevalence Study İn One Hospital. XVI. Annual Meeting of the European Society of Surgery Abstract Book 2012; 667-886
Llewellyn L. Effect of Pre-warming on Reducing the Incidence of Inadvertent Peri-operative Hypothermia for Patients Undergoing General Anaesthesia: A Mini-review. Br J Anaesth Recover Nurs. 2013;14(1-2):3-10


Responsible Party: Ali Kadir Değirmenci, Dokuz Eylul University
ClinicalTrials.gov Identifier: NCT02961244     History of Changes
Other Study ID Numbers: 870-GOA
First Submitted: November 1, 2016
First Posted: November 10, 2016
Results First Submitted: January 6, 2017
Results First Posted: May 11, 2017
Last Update Posted: December 12, 2017