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Clinical Trials/NCT04240236
NCT04240236
Completed
Not Applicable

Effect of Scalp Blocks on Postoperative Nausea & Vomiting & Recovery Profiles After Craniotomy: A Randomized, Double-Blind, and Controlled Study

Ain Shams University1 site in 1 country40 target enrollmentOctober 30, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Nausea and Vomiting
Sponsor
Ain Shams University
Enrollment
40
Locations
1
Primary Endpoint
PONV incidence & severity during the 1st 24 hours in ICU.
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

In this study, the investigators hypothesize that preemptive scalp block in neurosurgical patients may decrease incidence of PONV after craniotomy through decreasing intraoperative inhalational agents' concentration and decreasing intraoperative opioids requirements, with better intraoperative hemodynamics and lesser recovery time

Detailed Description

Patients will be recruited after admission to the hospital for surgery. Randomization will be performed using computer-generated random number tables in opaque sealed envelopes prepared by an anesthesiologist who will be not part of the study Patients will be randomly divided into two groups using a computer generated random number chart. Group S received scalp block with 20 ml of 0.5% bupivacaine, whereas Group C received scalp block using 20 mL normal saline and will be considered as control group.

Registry
clinicaltrials.gov
Start Date
October 30, 2019
End Date
July 1, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Raham Hasan Mostafa, MD

Assistant Professor of Anesthesia

Ain Shams University

Eligibility Criteria

Inclusion Criteria

  • ASA I and II patients,
  • aged 18 to 50 years,
  • 70-80 kg,
  • undergoing elective supratentorial craniotomy

Exclusion Criteria

  • patients under 18 years of age,
  • pregnancy,
  • emergency surgery,
  • patients with a Glasgow Coma Score (GCS) less than 15,
  • those with documented allergy to bupivacaine,
  • regular communication not possible,
  • Patients requiring prolonged mechanical ventilation (\> 2 hours after end of surgery) will be also excluded

Outcomes

Primary Outcomes

PONV incidence & severity during the 1st 24 hours in ICU.

Time Frame: 24 hours

The intensity of the PONV was classified as: 0: without PONV, 1: nausea, 2: vomiting and 3: vomiting more than 2 times \[8\]. In addition, the incidence of PONV, the first time there was need for ondansetron and its total dose was recorded. With PONV score ≥ 2, the investigators used 4 mg ondansetron IV for antiemetic regimen. The total dose over 24 hours (given as divided doses) must not exceed adult dose of 32 mg.

Secondary Outcomes

  • Total intraoperative fentanyl consumption in microgram(6 hours)
  • Recovery time in minutes(10 minutes)
  • Intraoperative Mean blood pressure in mmHg(6 hours)
  • Intraoperative Heart rate as number of beats per minute(6 hours)

Study Sites (1)

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