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Granisetron Effect on Hemodynamic Changes in Laparoscopic Cholecystectomy (lap)

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ClinicalTrials.gov Identifier: NCT03180229
Recruitment Status : Completed
First Posted : June 8, 2017
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Savas Altinsoy, Diskapi Yildirim Beyazit Education and Research Hospital

Tracking Information
First Submitted Date  ICMJE May 29, 2017
First Posted Date  ICMJE June 8, 2017
Last Update Posted Date October 1, 2019
Actual Study Start Date  ICMJE May 29, 2017
Actual Primary Completion Date September 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 8, 2017)
  • change mean arterial blood pressure [ Time Frame: Change from Baseline Systolic Blood Pressure at per 5 minute during surgery ]
    mean arterial blood pressure (MAP) MAP at least 25% less than the basal value
  • intubation quality [ Time Frame: intubation period ]
    in this time evans score which is included tears, sweating, systolic arterial blood pressure and heart rate will be used. the change baseline systolic arterial blood pressure and heart rate and tears, sweating will score numeric.
  • change heart rate [ Time Frame: Change from baseline heart rate at per 5 minute during surgery ]
    HR <60 or >25% drop baseline
Original Primary Outcome Measures  ICMJE
 (submitted: June 6, 2017)
  • change mean arterial blood pressure [ Time Frame: Change from Baseline Systolic Blood Pressure at per 5 minute during surgery ]
    mean arterial blood pressure (MAP) MAP at least 25% less than the basal value
  • intubation quality [ Time Frame: intubation period ]
    in this time evans score which is included tears, sweating, systolic arterial blood pressure and heart rate will be used. the change basline systolic arterial blood pressure and heart rate and tears, sweating will score numeric.
  • change heart rate [ Time Frame: Change from baseline heart rate at per 5 minute during surgery ]
    HR <60 or >25% drop baseline
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Granisetron Effect on Hemodynamic Changes in Laparoscopic Cholecystectomy
Official Title  ICMJE Granisetron Effect on Hemodynamic Changes and Intubation Condition During Anesthesia Induction in Laparoscopic Cholecystectomy
Brief Summary

Propofol is one of the most commonly used anesthetic agents because of its ability to induce rapid and reliable collection. However, hypotension and injection pain in the induction are the most common complications. After induction of propofol; The cardiovascular system depresses, resulting in a drop in blood pressure due to decreased cardiac output and systemic vascular resistance. This may also contribute to the reduction of sympathetic tone activity in the central way, and slight reduction in the number of pulses that develop as a result of increasing vagal activity. İn order to attenuate these hemodynamic undesired effects caused by propofol, various agents were tried such as atropine, ephedrine, volume replacement ringer lactate, ketamine. Ondansetron and granisetron, which are used for postoperative nausea and vomiting prophylaxis, have been used as such. Therefore, ondansetron and granisetron were preventing hypotension induced by post-spinal and general anesthesia induction.

The investigator also tried to demonstrate the effect of granisetron, another serotonin type 3 (5-HT3) receptor antagonist for postoperative nausea and vomiting prophylaxis, on induction hypotension and intubation quality after propofol induction in this study

Detailed Description

150 participants with American Society of Anesthesiologists (ASA) physical score I-II who underwent elective laparoscopic cholecystectomy between the ages of 18-70 will be enrolled. Participants will be divided into two groups using granisetron and control.

All participants will be premedicated with 0.05 mg kg-1 midazolam 30 minutes before the operation. ASA, age, sex, weight demographic data of the participants who were taken to the operating room will record. Peripheral oxygen saturation (SPO2), noninvasive blood pressure and electrocardiography (ECG) will monitored. A venous cannula will place on the back of the hand. Participants will randomly divide into 2 groups by closed envelope method.

Five minutes before the induction of group G, 1 ml (1 mg / ml) iv granisetron, group K will receive 1 ml saline. Propofol at induction will be administered at a dose of 0.6 mg / kg of rocuronium at a dose of 2 mg / kg. Pre-induction, post-intubation and every five minutes SPO2, diastolic arterial pressure (DAP), mean arterial pressure (MAP), systolic arterial pressure(SAP) and heart rate (HR) will record. Intubation quality will be evaluated by evans score.

Systolic Blood Pressure <Control + 15 0 <Control + 30 1 1

  • Control + 30 2 Heart Rate Pressure <Control + 15 0 <Control + 30 1
  • Control + 30 2 Sweating No 0 Moist leather 1 Visible sweating 2 Tears No 0 Yes 1 Overflowing 2
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Cholelithiasis
Intervention  ICMJE Drug: Granisetron 1 Mg/mL Intravenous Solution
1 milligram (mg) will use on group Granisetron before 5 min induction
Study Arms  ICMJE
  • Active Comparator: Granisetron
    Five minutes before the induction 1 ml (1 mg / ml) iv granisetron will use. .Then blood pressure (systolic, diastolic, mean) and heart rate will record per 5 minute during surgery.
    Intervention: Drug: Granisetron 1 Mg/mL Intravenous Solution
  • No Intervention: Control
    Five minutes before the induction 1 ml saline iv use.Then blood pressure (systolic, diastolic, mean) and heart rate will record per 5 minute during surgery.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 26, 2017)
140
Original Estimated Enrollment  ICMJE
 (submitted: June 6, 2017)
120
Actual Study Completion Date  ICMJE December 26, 2018
Actual Primary Completion Date September 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Laparoscopic Cholecystectomy (lap) surgery

Exclusion Criteria:

  • Acute pancreatitis disease
  • Cardiorespiratory disease
  • Hypertension
  • Anti hypertension treatments
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Gender Eligibility Description: 18-70
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03180229
Other Study ID Numbers  ICMJE Diskapi
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Savas Altinsoy, Diskapi Yildirim Beyazit Education and Research Hospital
Study Sponsor  ICMJE Diskapi Yildirim Beyazit Education and Research Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Diskapi Yildirim Beyazit Education and Research Hospital
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP