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IRCT20131228015963N10 IRCT 2023-12-23 Rasht University of Medical Sciences Comparison of the effect of different doses of intravenous dextrose solution on incidence and severity of postoperative nausea and vomiting Comparison of the effect of different doses of intravenous dextrose solution administered intraoperatively on incidence and severity of postoperative nausea and vomiting in patients undergoing rhinoplasty surgery (A randomized controlled trial) 2024-01-10 anticipated 144 Complete https://irct.ir/trial/74211 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: This research involves a randomized controlled trial of the equivalence type with a parallel study design. To allocate patients to intervention and control groups, we will utilize the approach of restricted randomization (block randomization) in parallel, considering blocks randomly with a size of 6. The generation of random numbers will be facilitated using a random number table (Random Allocation software). Allocation concealment will be employed to conceal and manage confounding factors. This method ensures the implementation of a random sequence for participant allocation in the study, thereby not specifying the assigned group before individual assignment. This method involves the use of sealed envelopes, each containing a recorded random sequence card. These cards are arranged within the envelopes in a specific order, with the outer surface of the envelopes numbered accordingly. During the registration of eligible patients for the study, one of the envelopes will be opened sequentially, determining whether the patient will receive different doses of intravenous dextrose solution or be placed in the control group, Blinding description: This study is conducted in a double-blind manner, which includes participants and outcome assessors. In both the intervention and control groups, blinding will be done completely, the syringes and materials of the intervention and placebo will be the same in terms of color. Blinding will be done on injectable serums and syringes with specified codes. The outcome assessors also do not know the nature of the injection solution. 3 Postoperative nausea and vomiting. Intervention 1: Intervention group 1: Like the control group, will receive 5 mL/kg of ringer lactate serum as compensatory intravascular volume expansion (CVE) and maintenance serum during surgery (40 mL for the first 10 kg per hour, 20 mL for the second 10 kg per hour and for each subsequent 1 kg per hour, 1 mL); with the difference that intervention group 1 will receive 500 mL of D5 solution (containing 25 g of glucose) in addition to the same serums described above. The total serum will be injected from the start of anesthesia to the patients of this group for 60 minutes. Intervention 2: Intervention group 2: Like the control group, will receive 5 mL/kg of ringer lactate serum as compensatory intravascular volume expansion (CVE) and maintenance serum during surgery (40 mL for the first 10 kg per hour, 20 mL for the second 10 kg per hour and for each subsequent 1 kg per hour, 1 mL); with the difference that intervention group 2 will receive 500 mL of D10 solution (containing 50g of glucose) in addition to the same serums described above. The total serum will be injected from the start of anesthesia to the patients of this group for 60 minutes. Intervention 3: Control group: Will receive 5 mL/kg ringer lactate serum as compensatory intravascular volume expansion (CVE) and receive maintenance serum during surgery (40 mL for the first 10 kg per hour, 20 mL for the second 10 kg per hour, and 1 mL for each subsequent 1 kg per hour) like other groups. And unlike the two intervention groups, they will receive 500 mL of ringer lactate in addition to the above serums. The total serum will be injected to the patients of this group for 60 minutes from the start of anesthesia. Yes - There is a plan to make this available What will be shared: Demographic characteristics of participants that affect outcomes and the type of intervention and outcomes are shared. When: The access period starts 3 months after the results are published To whom: Researchers and people who are engaged in the clinical field under study can apply for them. Conditions: Researchers who are engaged in the clinical field of study can apply to receive them. Where to obtain: Project implementers in Amir al-Momenin Hospital in Rasht Doctor Soodabeh Haddadi so_haddadi@gums.ac.ir Alireza Mofid Nakhaei alireza.mofidnakhaei@gmail.com How to obtain: The request for project data and information should be done in coordination with the project implementers. Comments:
public Alireza Mofid Nakhaei
Amir Al Mo’menin Hospital - 17th Shahrivar St. - Hafez Boulevard - Rasht - Gilan – Iran
Rasht Iran (Islamic Republic of) 3845941396 +98 13 3323 8306 so_haddadi@gums.ac.ir Rasht University of Medical Sciences scientific Alireza Mofid Nakhari
Amir Al Mo’menin Hospital - 17th Shahrivar St. - Hafez Boulevard - Rasht - Gilan – Iran
Rasht Iran (Islamic Republic of) 3845941396 +98 13 3323 8306 so_haddadi@gums.ac.ir Rasht University of Medical Sciences Iran (Islamic Republic of) Female patients aged 18 to 65 undergoing rhinoplasty Patients who are candidates for rhinoplasty surgery Patients in ASA Ⅰ and ASA Ⅱ class 18 years 65 years Female History of diabetes mellitus (DM) Known congestive heart failure (CHF) Pregnant women Recent opioid use (within 48 hours before surgery) Having a history of postoperative nausea and vomiting (PONV) or motion sickness Smoker patients Known renal or hepatic failure or impaired preoperative tests Patients who have used anti-nausea medication 24 hours before surgery. Patients who have abnormal blood sugar on the morning of surgery. (Blood sugar more than 125 mg/dL) Known sensitivity to anesthetics used in the study R11.2 تهوع و استفراغ بعد از عمل (Postoperative nausea and vomiting) Prevention Prevention Prevention Intervention group 1: Like the control group, will receive 5 mL/kg of ringer lactate serum as compensatory intravascular volume expansion (CVE) and maintenance serum during surgery (40 mL for the first 10 kg per hour, 20 mL for the second 10 kg per hour and for each subsequent 1 kg per hour, 1 mL); with the difference that intervention group 1 will receive 500 mL of D5 solution (containing 25 g of glucose) in addition to the same serums described above. The total serum will be injected from the start of anesthesia to the patients of this group for 60 minutes. Intervention group 2: Like the control group, will receive 5 mL/kg of ringer lactate serum as compensatory intravascular volume expansion (CVE) and maintenance serum during surgery (40 mL for the first 10 kg per hour, 20 mL for the second 10 kg per hour and for each subsequent 1 kg per hour, 1 mL); with the difference that intervention group 2 will receive 500 mL of D10 solution (containing 50g of glucose) in addition to the same serums described above. The total serum will be injected from the start of anesthesia to the patients of this group for 60 minutes. Control group: Will receive 5 mL/kg ringer lactate serum as compensatory intravascular volume expansion (CVE) and receive maintenance serum during surgery (40 mL for the first 10 kg per hour, 20 mL for the second 10 kg per hour, and 1 mL for each subsequent 1 kg per hour) like other groups. And unlike the two intervention groups, they will receive 500 mL of ringer lactate in addition to the above serums. The total serum will be injected to the patients of this group for 60 minutes from the start of anesthesia. Comparison of the effect of different doses of intravenous dextrose solution administered intraoperatively on incidence and severity of postoperative nausea and vomiting. Timepoint: The incidence and severity of postoperative nausea and vomiting, based on the Visual analog nausea score, will be measured and recorded by nurses immediately, 30 minutes, 60 minutes, 90 minutes, 3 hours, 6 hours, 12 hours and 24 hours after entering the ward. In case of discharge in less than 24 hours, during a phone call, the patient's nausea and vomiting will be recorded, as well as the amount of anti-nausea medication (in the amount of 4 mg of intravenous and oral ondansetron during hospitalization or after discharge in case of vomiting). The duration of recovery will be recorded in all three groups. Also, blood sugar will be checked and recorded immediately, 30 minutes, 60 minutes, 90 minutes, 3 hours, 6 hours, 12 hours and 24 hours after the operation (if there is no glucose intolerance and the patients are discharged , blood sugar measurement will be stopped). An increase in blood sugar to more than 200 mg/dL will require intervention. The intervention method is the injection of 1 unit of short-acting insulin (like regular insulin) for every 25 mg/dL increase in blood sugar greater than 200 mg/dL. Method of measurement: Incidence and severity of nausea and vomiting (PONV), based on Visual analog nausea score criteria, immediately, 30 minutes, 60 minutes, 90 minutes, 3 hours, 6 hours, 12 hours and 24 hours after entering the ward, need for anti-inflammatory drugs Nausea (the amount consumed after 24 hours) of the patients and the duration of hospitalization are recorded according to a questionnaire that will be designed by the researcher. Rasht University of Medical Sciences Approved 2023-11-15 Research Ethics Committees of Guilan University of Medical Sciences Amir Al Mo’menin Hospital - 17th Shahrivar St. - Hafez Boulevard - Rasht - Gilan – Iran Rasht Guilan Iran (Islamic Republic of)