Adverse Effect of Drugs and Medicaments in Therapeutic UsePhase 4OpioidfreeNCT04048200
The Effect of Opioid Free Anesthesia in Bariatric Surgeries
A Phase 4 study testing Fentanyl and Dexmedetomidine Ketamine in people with Adverse Effect of Drugs and Medicaments in Therapeutic Use and Adverse Effects in the Therapeutic Use of Anaesthetics, run by Tanta University at 1 site in Egypt.
Trial summary
This is a prospective randomized controlled study that will be carried out on morbid obese patients admitted to Tanta University hospitals for laparoscopic bariatric surgeries. The patients will be randomly assigned into;- Control group:- Anesthesia will be induced by fentanyl 1 ug/kg, propofol 2 mg/kg, and rocuronium… Read more about this study
- Who is it for?
- Ages 21 to 50 years
- Conditions the study is for
- Adverse Effect of Drugs and Medicaments in Therapeutic Use, Adverse Effects in the Therapeutic Use of Anaesthetics
- What is being tested?
- Fentanyl and Dexmedetomidine Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2019to 15 Jun 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Morbid obese patients with BMI 40-50 kg/m2
- Aged more than 21 years and American Society of Anesthesiologists Class III
- Presented for laparoscopic sleeve gastrectomy or gastric bypass.
Who cannot join
- Patients refused to participate.
- Patients with known or suspected or known allergy to the used medication.
- Patients with moderate to severe obstructive sleep apnea
- Patients with uncontrolled blood sugar, cardiac, renal, or hepatic functions.
- Patients receiving opioids preoperatively
- Uncooperative patients
- Patients received preoperative gabapentoids.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Opioid Free Anesthesia on the Postoperative Opioid Consumption in Laparoscopic Bariatric Surgeries: Randomized Controlled Study
This is a prospective randomized controlled study that will be carried out on morbid obese patients admitted to Tanta University hospitals for laparoscopic bariatric surgeries. The patients will be randomly assigned into;- Control group:- Anesthesia will be induced by fentanyl 1 ug/kg, propofol 2 mg/kg, and rocuronium 1 mg/kg to facilitate tracheal intubation. Anesthesia will be maintained by sevoflurane 2% in a mixture of oxygen: Air 1: 1 to maintain entropy 40-60.
Opioid free anesthesia group;- Anesthesia will be induced by propofol 2 mg/kg, rocuronium 1 mg/kg to facilitate tracheal intubation. After endotracheal intubation, and a combination of dexmedetomidine and ketamine infusion. Anesthesia will be maintained by sevoflurane 2% in a mixture of oxygen: Air 1: 1 and continuing the infusion of dexmedetomidine and ketamine o maintain entropy 40-60.
Read the detailed description
This prospective randomized controlled study will be carried out on patients who will be presented for laparoscopic bariatric surgery in the general surgery department in Tanta university hospitals over six-month duration that will start immediately after obtaining ethical committee approval and clinical trial registration. An informed written consent will be obtained from all the participants, all patients data will be confidential and will be used for the current study only.
Inclusion criteria:
Morbid obese patients with BMI 40-50 kg/m2 aged more than 21 years and American Society of Anesthesiologists Class III presented for laparoscopic sleeve gastrectomy or gastric bypass.
Exclusion criteria:
- Patients refused to participate.
- Patients with known or suspected or known allergy to the used medication.
- Patients with moderate to severe obstructive sleep apnea
- Patients with uncontrolled blood sugar, cardiac, renal, or hepatic functions.
- Patients receiving opioids preoperatively
- Uncooperative patients
- Patients received preoperative gabapentoids.
Anesthetic technique Once the patients will arrive to the operating room, intravascular access will be established, fluid preload will be started, and basic monitor will be attached.
The patients will be randomly distributed into two equal groups by the aid of computer-generated software of randomization: - ▪ Control group (30 patients): Anesthesia will be induced by fentanyl 1 ug/kg, propofol 2 mg/kg, and rocuronium 1 mg/kg to facilitate tracheal intubation. After endotracheal intubation, Anesthesia will be maintained by sevoflurane 2% in a mixture of oxygen: Air 1: 1 to maintain entropy 40-60. The patients in this group will be connected to a syringe pump before induction of anesthesia that was prepared by anesthesia resident not participating in the study and contain normal saline and adjusted at a rate of 1 ml/kg/hr till the end of the surgery.
▪ Opioid free anesthesia group (30 patients): A syringe 50 ml was prepared by anesthesia resident not participating in the study and contain 100 ug of dexmedetomidine (2 ug/ml) and 25 mg ketamine 90.5 mg/ml) and 200 mg lidocaine (4 mg/ml). The syringe will be connected to the patients before induction of anesthesia at a rate of 0.1 ml/kg/hr according to the ideal body weight. Anesthesia will be induced by propofol 2 mg/kg, and rocuronium 1 mg/kg to facilitate tracheal intubation. Anesthesia will be maintained by sevoflurane 2% in a mixture of oxygen: Air 1: 1 to maintain entropy 40-60. The syringe infusion will be continued till the end of peritoneal manipulation. Patients in this group will receive magnesium sulphate preload at a dose of 40 mg/kg ideal body weight followed by maintenance infusion of 10 mg/kg/hr.
In both groups, routine anti-emetic prophylaxis will be administrated composed of ondansetron 4 mg and dexamethasone 8 mg before the surgery. Additional analgesia will be provided using 1 gm of paracetamol together with intraperitoneal local anesthetics and wound infiltration.
All the patients will be connected to the bispectral index monitor with maintaining its value 40-60. Increase in n bispectral index value above 60 will be managed by additional dose of fentanyl 0.5 ug/kg IBW and increasing the concentration of sevoflurane by 0.2% till the value decreased below 60.
At the end of the surgery, the inhalational anesthesia will be switched off with reversal of muscle relaxation using neostigmine and atropine with full awake extubation of the patient. The patients will be transported to the recovery room for adequate postoperative monitoring and management.
Measurements:
- Patient age, weight, height.
- The total dose consumption of fentanyl consumed intraopeartively.
- The total volume consumed of sevoflureane intraoperatively (ml/hr).
- The postoperative Visual Analogue Score (VAS): It will be measured every 2 hours till 6 h, then every 4 h till 24 h. In case of increase the VAS more than 3, a rescue analgesia will be administrated in the form of 2mg morphine i.v that may be repeated.
- The time for the first request of morphine rescue analgesia
- The total dose of morphine consumed in the first 24 h after surgery
- The recovery profile of the patient.
- Patients satisfaction.
- Conditions
- Adverse Effect of Drugs and Medicaments in Therapeutic Use, Adverse Effects in the Therapeutic Use of Anaesthetics
- Being tested
- Fentanyl, Dexmedetomidine Ketamine
- Keywords
- Dexmedetomidine, Ketamine, Fentanyl, Bariatric surgeries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
Also called Opioid based Anesthesia
Anesthesia will be induced by fentanyl, propofol, and rocuronium with maintenance of anesthesia using sevoflurane.
Dexmedetomidine KetamineDrug
Also called Opioid sparing
No opioid will be used in induction of anesthesia. A combination of dexmedetomidine and ketamine will be infused. Sevoflurane will be used for maintenance of anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | Anesthesia will be induced by fentanyl 1 ug/kg, propofol 2 mg/kg, and rocuronium 1 mg/kg to facilitate tracheal intubation. After endotracheal intubation, the patients will be connected to mechanical ventilator with its parameters adjusted to maint5ain etCO2 32-36 mmhg. Anesthesia will be maintained by sevoflurane 2% in a mixture of oxygen: Air 1: 1 to maintain entropy 40-60. The patients in this group will be connected to a syringe pump before induction of anesthesia that was prepared by anesthesia resident not participating in the study and contain normal saline and adjusted at a rate of 1 ml/kg/hr till the end of the surgery. Receives: Drug: Fentanyl |
| Opioid free anesthesia group | Experimental | A syringe 50 ml was prepared by anesthesia resident not participating in the study and contain 100 ug of dexmedetomidine (2 ug/ml) and 25 mg ketamine 90.5 mg/ml) and 200 mg lidocaine (4 mg/ml). The syringe will be connected to the patients before induction of anesthesia at a rate of 0.1 ml/kg/hr according to the ideal body weight. Anesthesia will be induced by propofol 2 mg/kg, and rocuronium 1 mg/kg to facilitate tracheal intubation. After endotracheal intubation, the patients will be connected to mechanical ventilator with its parameters adjusted to maint5ain etCO2 32-36 mmhg. Anesthesia will be maintained by sevoflurane 2% in a mixture of oxygen: Air 1: 1 to maintain entropy 40-60. The syringe infusion will be continued till the end of peritoneal manipulation. Patients in this group will receive magnesium sulphate preload at a dose of 40 mg/kg ideal body weight followed by maintenance infusion of 10 mg/kg/hr. Receives: Drug: Dexmedetomidine Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative opioid consumption
The total dose of morphine consumed postoperative as a rescue analgesia to maintain the VAS less than 4
Measured: The first 24 hours postoperatively
Secondary outcomes (1)
Intraoperative sevoflurane consumption
The intraoperative consumption of sevoflurane in ml per one hour
Measured: Through out the whole intraoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start1 Sep 2019
- Primary completion15 Jun 2020
- Study completion15 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse Effect of Drugs and Medicaments in Therapeutic UseStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh Abdelkhalik Ahmed Ismaiel, Tanta University
- Investigators
- Sameh Ismaiel, M.D, Principal investigator, Lecturer of Anesthesia and Intensive Care, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04048200
- Sponsor's protocol ID
- 33107/05/19
- Other IDs
- Tanta University
- Acronym
- Opioidfree
- Status last verified
- Jun 2020
- First submitted
- 6 Aug 2019
- Last updated
- 18 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Once the study had been successfully completed, the data will be shared for other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Opioid Free Anesthesia on the Postoperative Opioid Consumption in Laparoscopic Bariatric Surgeries: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04048200
- Acronym / sponsor ID
- Opioidfree / 33107/05/19
- Conditions
- Adverse Effect of Drugs and Medicaments in Therapeutic Use, Adverse Effects in the Therapeutic Use of Anaesthetics
- Keywords
- Dexmedetomidine, Ketamine, Fentanyl, Bariatric surgeries
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 15 Jun 2020 (actual)
- First posted
- 7 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective randomized controlled study that will be carried out on morbid obese patients admitted to Tanta University hospitals for laparoscopic bariatric surgeries. The patients will be randomly assigned into;- Control group:- Anesthesia will be induced by fentanyl 1 ug/kg, propofol 2 mg/kg, and rocuronium 1 mg/kg to facilitate tracheal intubation. Anesthesia will be maintained by sevoflurane 2% in a mixture of oxygen: Air 1: 1 to maintain entropy 40-60.
Opioid free anesthesia group;- Anesthesia will be induced by propofol 2 mg/kg, rocuronium 1 mg/kg to facilitate tracheal intubation. After endotracheal intubation, and a combination of dexmedetomidine and ketamine infusion. Anesthesia will be maintained by sevoflurane 2% in a mixture of oxygen: Air 1: 1 and continuing the infusion of dexmedetomidine and ketamine o maintain entropy 40-60.
Detailed description
This prospective randomized controlled study will be carried out on patients who will be presented for laparoscopic bariatric surgery in the general surgery department in Tanta university hospitals over six-month duration that will start immediately after obtaining ethical committee approval and clinical trial registration. An informed written consent will be obtained from all the participants, all patients data will be confidential and will be used for the current study only.
Inclusion criteria:
Morbid obese patients with BMI 40-50 kg/m2 aged more than 21 years and American Society of Anesthesiologists Class III presented for laparoscopic sleeve gastrectomy or gastric bypass.
Exclusion criteria:
- Patients refused to participate.
- Patients with known or suspected or known allergy to the used medication.
- Patients with moderate to severe obstructive sleep apnea
- Patients with uncontrolled blood sugar, cardiac, renal, or hepatic functions.
- Patients receiving opioids preoperatively
- Uncooperative patients
- Patients received preoperative gabapentoids.
Anesthetic technique Once the patients will arrive to the operating room, intravascular access will be established, fluid preload will be started, and basic monitor will be attached.
The patients will be randomly distributed into two equal groups by the aid of computer-generated software of randomization: - ▪ Control group (30 patients): Anesthesia will be induced by fentanyl 1 ug/kg, propofol 2 mg/kg, and rocuronium 1 mg/kg to facilitate tracheal intubation. After endotracheal intubation, Anesthesia will be maintained by sevoflurane 2% in a mixture of oxygen: Air 1: 1 to maintain entropy 40-60. The patients in this group will be connected to a syringe pump before induction of anesthesia that was prepared by anesthesia resident not participating in the study and contain normal saline and adjusted at a rate of 1 ml/kg/hr till the end of the surgery.
▪ Opioid free anesthesia group (30 patients): A syringe 50 ml was prepared by anesthesia resident not participating in the study and contain 100 ug of dexmedetomidine (2 ug/ml) and 25 mg ketamine 90.5 mg/ml) and 200 mg lidocaine (4 mg/ml). The syringe will be connected to the patients before induction of anesthesia at a rate of 0.1 ml/kg/hr according to the ideal body weight. Anesthesia will be induced by propofol 2 mg/kg, and rocuronium 1 mg/kg to facilitate tracheal intubation. Anesthesia will be maintained by sevoflurane 2% in a mixture of oxygen: Air 1: 1 to maintain entropy 40-60. The syringe infusion will be continued till the end of peritoneal manipulation. Patients in this group will receive magnesium sulphate preload at a dose of 40 mg/kg ideal body weight followed by maintenance infusion of 10 mg/kg/hr.
In both groups, routine anti-emetic prophylaxis will be administrated composed of ondansetron 4 mg and dexamethasone 8 mg before the surgery. Additional analgesia will be provided using 1 gm of paracetamol together with intraperitoneal local anesthetics and wound infiltration.
All the patients will be connected to the bispectral index monitor with maintaining its value 40-60. Increase in n bispectral index value above 60 will be managed by additional dose of fentanyl 0.5 ug/kg IBW and increasing the concentration of sevoflurane by 0.2% till the value decreased below 60.
At the end of the surgery, the inhalational anesthesia will be switched off with reversal of muscle relaxation using neostigmine and atropine with full awake extubation of the patient. The patients will be transported to the recovery room for adequate postoperative monitoring and management.
Measurements:
- Patient age, weight, height.
- The total dose consumption of fentanyl consumed intraopeartively.
- The total volume consumed of sevoflureane intraoperatively (ml/hr).
- The postoperative Visual Analogue Score (VAS): It will be measured every 2 hours till 6 h, then every 4 h till 24 h. In case of increase the VAS more than 3, a rescue analgesia will be administrated in the form of 2mg morphine i.v that may be repeated.
- The time for the first request of morphine rescue analgesia
- The total dose of morphine consumed in the first 24 h after surgery
- The recovery profile of the patient.
- Patients satisfaction.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective study
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Drug: FentanylAnesthesia will be induced by fentanyl 1 ug/kg, propofol 2 mg/kg, and rocuronium 1 mg/kg to facilitate tracheal intubation. After endotracheal intubation, the patients will be connected to mechanical ventilator with its parameters adjusted to maint5ain etCO2 32-36 mmhg. Anesthesia will be maintained by sevoflurane 2% in a mixture of oxygen: Air 1: 1 to maintain entropy 40-60. The patients in this group will be connected to a syringe pump before induction of anesthesia that was prepared by anesthesia resident not participating in the study and contain normal saline and adjusted at a rate of 1 ml/kg/hr till the end of the surgery. |
| Opioid free anesthesia group | Experimental | Drug: Dexmedetomidine KetamineA syringe 50 ml was prepared by anesthesia resident not participating in the study and contain 100 ug of dexmedetomidine (2 ug/ml) and 25 mg ketamine 90.5 mg/ml) and 200 mg lidocaine (4 mg/ml). The syringe will be connected to the patients before induction of anesthesia at a rate of 0.1 ml/kg/hr according to the ideal body weight. Anesthesia will be induced by propofol 2 mg/kg, and rocuronium 1 mg/kg to facilitate tracheal intubation. After endotracheal intubation, the patients will be connected to mechanical ventilator with its parameters adjusted to maint5ain etCO2 32-36 mmhg. Anesthesia will be maintained by sevoflurane 2% in a mixture of oxygen: Air 1: 1 to maintain entropy 40-60. The syringe infusion will be continued till the end of peritoneal manipulation. Patients in this group will receive magnesium sulphate preload at a dose of 40 mg/kg ideal body weight followed by maintenance infusion of 10 mg/kg/hr. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Morbid obese patients with BMI 40-50 kg/m2
- Aged more than 21 years and American Society of Anesthesiologists Class III
- Presented for laparoscopic sleeve gastrectomy or gastric bypass.
Key exclusion criteria (7 listed)
- Patients refused to participate.
- Patients with known or suspected or known allergy to the used medication.
- Patients with moderate to severe obstructive sleep apnea
- Patients with uncontrolled blood sugar, cardiac, renal, or hepatic functions.
- Patients receiving opioids preoperatively
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FentanylAlso: Opioid based AnesthesiaAnesthesia will be induced by fentanyl, propofol, and rocuronium with maintenance of anesthesia using sevoflurane. | Drug | Control group |
| Dexmedetomidine KetamineAlso: Opioid sparingNo opioid will be used in induction of anesthesia. A combination of dexmedetomidine and ketamine will be infused. Sevoflurane will be used for maintenance of anesthesia. | Drug | Opioid free anesthesia group |
Primary outcome
Postoperative opioid consumption
Time frame: The first 24 hours postoperatively
The total dose of morphine consumed postoperative as a rescue analgesia to maintain the VAS less than 4
1 secondary outcome
Intraoperative sevoflurane consumption
Time frame: Through out the whole intraoperative period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
- Individual participant dataSharing planned: No. Once the study had been successfully completed, the data will be shared for other researchers.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sameh Ismaiel, M.D principal investigator
Lecturer of Anesthesia and Intensive Care, Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fentanyl and Dexmedetomidine Ketamine in people with Adverse Effect of Drugs and Medicaments in Therapeutic Use and Adverse Effects in the Therapeutic Use of Anaesthetics, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative opioid consumption (time frame: The first 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2020.