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)

Comparison of the effect of injecting different doses of intravenous dextrose solution intraoperatively on the incidence and severity of postoperative nausea and vomiting in rhinoplasty patients.

Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 144 patients. Random Allocation software is used for randomization.

Injection of different doses of dextrose solution (containing 25 grams and 50 grams of glucose in the two intervention groups) and comparing it with placebo injection (containing ringer lactate in the control group) and together, in patients undergoing rhinoplasty at Amir al-Momenin Hospital in Rasht. Participants and outcome assessors do not know the nature of the injection solution.

Entry requirements: Female patients aged 18 to 65 undergoing rhinoplasty Non-entry conditions: History of underlying diseases such as diabetes, heart, liver and kidney failure and history of sensitivity to the anesthetics of study

There are two intervention groups. Both intervention groups, like the control group, receive 5 mL/kg of ringer lactate serum as 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 for each subsequent 1 kg per hour, 1 mL) are placed; with the difference that intervention group 1 receives 500 mL of D5 solution (containing 25 g of glucose) and intervention group 2 receives 500 mL of D10 solution (containing 50 g of glucose) in addition to the same serums described above. The total serum will be injected.

Incidence and severity of nausea and vomiting 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.

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.

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.

Demographic characteristics of participants that affect outcomes and the type of intervention and outcomes are shared.

The access period starts 3 months after the results are published

Researchers and people who are engaged in the clinical field under study can apply for them.

Researchers who are engaged in the clinical field of study can apply to receive them.

Project implementers in Amir al-Momenin Hospital in Rasht Doctor Soodabeh Haddadi so_haddadi@gums.ac.ir Alireza Mofid Nakhaei alireza.mofidnakhaei@gmail.com

The request for project data and information should be done in coordination with the project implementers.