Granisetron Effect on Hemodynamic Changes in Laparoscopic Cholecystectomy (lap)

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

Tracking Information

• First Submitted Date: May 29, 2017
• First Posted Date: June 8, 2017
• Last Update Posted Date: October 1, 2019
• Actual Study Start Date: May 29, 2017
• Actual Primary Completion Date: September 1, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Granisetron Effect on Hemodynamic Changes in Laparoscopic Cholecystectomy
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Prevention
• Condition: Cholelithiasis

Intervention

Drug: Granisetron 1 Mg/mL Intravenous Solution

1 milligram (mg) will use on group Granisetron before 5 min induction

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 26, 2017): 140
• Original Estimated Enrollment (submitted: June 6, 2017): 120
• Actual Study Completion Date: December 26, 2018
• Actual Primary Completion Date: September 1, 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Laparoscopic Cholecystectomy (lap) surgery

Exclusion Criteria:

• Acute pancreatitis disease
• Cardiorespiratory disease
• Hypertension
• Anti hypertension treatments

Sex/Gender

• Sexes Eligible for Study: All
• Gender Based Eligibility: Yes
• Gender Eligibility Description: 18-70

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Turkey

Administrative Information

• NCT Number: NCT03180229
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Savas Altinsoy, Diskapi Yildirim Beyazit Education and Research Hospital
• Study Sponsor: Diskapi Yildirim Beyazit Education and Research Hospital
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Diskapi Yildirim Beyazit Education and Research Hospital
• Verification Date: September 2019