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

NCT05057767 | Completed

• 1 other identifier: RC-12-8-2021
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

• Post Operative Nausea Vomiting assessment

  Nausea will be recorded according to the following scale: 0 none; 1 mild (patient able to eat); 2 moderate (oral intake significantly decreased); and 3 severe (no significant oral intake necessitating iv fluid). The absence of nausea will be defined as complete protection from nausea. An emetic episode will be defined as a single vomit or retch, or any number of continuous vomiting episodes or retches (one emetic episode should be separated from another by an absence of vomiting or retching for at least 1 min). The absence of emetic episodes will be defined as complete protection from vomiting.

  24 hours postoperative

Secondary Outcomes (3)

• requirements of rescue antiemetic

  24 hours postoperative

• Observer's Assessment of Alertness/ Sedation (OAA/S) scale

  120 minutes postoperative

• Pain intensity score

  24 hours postoperative

Study Arms (3)

Pre-induction Group (I)

EXPERIMENTAL

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

Drug: Midazolam injection

Pre-extubation Group (II)

EXPERIMENTAL

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

Drug: Midazolam injection

Control Group (III)

PLACEBO COMPARATOR

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.

Drug: Midazolam injection

Interventions

Midazolam injection DRUG

No premedication will be given to Patients in the group undergoing a standardized anesthesia protocol which include induction with thiopental (5 mg/kg) and fentanyl (1-2 μg/kg). Atracurium will be used as a muscle relaxant. After tracheal intubation, anesthesia will be maintained with isoflurane in a concentration of 0.8%-1.2%. Ventilation will be adjusted to produce normocapnia. At the end of surgery, reversal of residual neuromuscular blockade will be accomplished using i.v. atropine 20 μg/Kg and neostigmine 40 μg/kg.

Control Group (III); Pre-extubation Group (II); Pre-induction Group (I)

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Samar Rafik Mohamed Amin

Banhā, Qalyubia Governorate, 13511, Egypt

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Midazolam

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia and surgical ICU

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: September 27, 2021
• Study Start: September 10, 2021
• Primary Completion: June 30, 2022
• Study Completion: July 31, 2022
• Last Updated: August 16, 2022

Record last verified: 2021-09

Locations

EG (1)