Impact of Timing of Midazolam Administration on Incidence of Postoperative Nausea and Vomiting

Benha University

Status: Completed

Conditions: Postoperative Nausea and Vomiting

Treatments: Drug: Midazolam injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05057767

RC-12-8-2021

Details and patient eligibility

About

Postoperative nausea and vomiting (PONV), defined as nausea and/or vomiting occurring within 24 hours after surgery, affects between 20% and 30% of patients, As many as 70% to 80% of patients at high risk may be affected. The etiology of PONV is thought to be multifactorial, involving individual, anaesthetic and surgical risk factors. PONV results in increased patient discomfort and dissatisfaction and in increased costs related to length of hospital stay. Serious medical complications such as pulmonary aspiration, although uncommon, are also associated with vomiting.

Patients with a higher risk of PONV often require a combination or multimodal approach of 2 or more interventions for effective risk reduction. Thus, researchers have explored additional nontraditional antiemetics, such as midazolam, that would aid in the multimodal prevention of PONV.

Full description

Midazolam is often administered in the perioperative period to reduce anxiety in addition to causing sedation and amnesia. The pharmacologic qualities allow for a rapid onset, short duration, and short half-life. The clinical effects of midazolam result from an agonist action on the γ-aminobutyric acid A (GABAA) receptor throughout the central nervous system. Benzodiazepines do not work directly on the GABA receptor, so there is a physiologic ceiling effect, which contributes to their safety and low toxicity.

Although the exact antiemetic mechanisms remain unknown, researchers postulate that midazolam works on the chemoreceptor trigger zone by reducing the synthesis, release, and postsynaptic dopamine. It remains debatable whether midazolam reduces dopamine directly or blocks the reuptake of adenosine leading to an adenosine-mediated reduction of dopamine release. Additionally, the binding of midazolam to the GABA benzodiazepine complex may cause dopaminergic neuronal activity and the release of 5-hydroxytryptamine. The reduction of PONV may also be a secondary effect of the anxiolytic properties of benzodiazepines.

Despite literature demonstrating the PONV benefits of midazolam in the perioperative period, But the timing of administration of this drug is still not well established. As it is known that it has half-life of about 1.5 - 2.5 hours and the controversies remain whether to administer this drug preoperatively or postoperatively to prevent PONV. So this comparative study is designed to know the better time for administration of this drug to prevent PONV and to improve patient satisfaction.

Enrollment: 120 patients

Sex: Female

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Female patients
• aged twenty to sixty years old
• The American Society of Anesthesiologists (ASA) physical status classification grade I or II
• Scheduled for laparoscopic gynecological surgeries under general anesthesia.

Exclusion criteria

• Patients who have gastrointestinal disorders,
• histories of PONV after a previous surgery,
• Renal or liver dysfunction,
• history of motion sickness,
• Have received any opioid, steroid, or antiemetic medication in the 24hs before surgery, and
• Pregnant or menstruating women.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups, including a placebo group

Pre-induction Group (I)

Experimental group

Description:

will receive intravenous midazolam premedication 2mg in a volume of 3 ml, 15 minutes before induction of anesthesia

Treatment:

Drug: Midazolam injection

Pre-extubation Group (II)

Experimental group

Description:

will receive intravenous midazolam 2mg in a volume of 3 ml 30 minutes before extubation at the end of surgery

Treatment:

Drug: Midazolam injection

Control Group (III)

Placebo Comparator group

Description:

will receive 3 ml normal saline 15 minutes before induction of anesthesia plus 3 ml normal saline 30 minutes before extubation at the end of surgery.

Treatment:

Drug: Midazolam injection