Granisetron Effect on Hemodynamic Changes in Laparoscopic Cholecystectomy (lap)
Primary Purpose
Cholelithiasis
Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Granisetron 1 Mg/mL Intravenous Solution
Sponsored by
About this trial
This is an interventional prevention trial for Cholelithiasis
Eligibility Criteria
Inclusion Criteria:
- Laparoscopic Cholecystectomy (lap) surgery
Exclusion Criteria:
- Acute pancreatitis disease
- Cardiorespiratory disease
- Hypertension
- Anti hypertension treatments
Sites / Locations
- Ministry of Health Diskapi Yıldırım Beyazıt Training and Research Hospital Ankara, Turkey
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Granisetron
Control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
change mean arterial blood pressure
mean arterial blood pressure (MAP) MAP at least 25% less than the basal value
intubation quality
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
HR <60 or >25% drop baseline
Secondary Outcome Measures
Full Information
NCT ID
NCT03180229
First Posted
May 29, 2017
Last Updated
September 27, 2019
Sponsor
Diskapi Yildirim Beyazit Education and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03180229
Brief Title
Granisetron Effect on Hemodynamic Changes in Laparoscopic Cholecystectomy
Acronym
lap
Official Title
Granisetron Effect on Hemodynamic Changes and Intubation Condition During Anesthesia Induction in Laparoscopic Cholecystectomy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
May 29, 2017 (Actual)
Primary Completion Date
September 1, 2017 (Actual)
Study Completion Date
December 26, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diskapi Yildirim Beyazit Education and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholelithiasis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Granisetron
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Granisetron 1 Mg/mL Intravenous Solution
Intervention Description
1 milligram (mg) will use on group Granisetron before 5 min induction
Primary Outcome Measure Information:
Title
change mean arterial blood pressure
Description
mean arterial blood pressure (MAP) MAP at least 25% less than the basal value
Time Frame
Change from Baseline Systolic Blood Pressure at per 5 minute during surgery
Title
intubation quality
Description
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.
Time Frame
intubation period
Title
change heart rate
Description
HR <60 or >25% drop baseline
Time Frame
Change from baseline heart rate at per 5 minute during surgery
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
18-70
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Laparoscopic Cholecystectomy (lap) surgery
Exclusion Criteria:
Acute pancreatitis disease
Cardiorespiratory disease
Hypertension
Anti hypertension treatments
Facility Information:
Facility Name
Ministry of Health Diskapi Yıldırım Beyazıt Training and Research Hospital Ankara, Turkey
City
Ankara
Country
Turkey
12. IPD Sharing Statement
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Granisetron Effect on Hemodynamic Changes in Laparoscopic Cholecystectomy
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