Dexmedetomidine and Laparoscopic Surgery

Not Applicable

Completed

• Conditions: Anesthesia Complication
• Interventions: Drug: Normal saline; Drug: Dexmedetomidine

• Registration Number: NCT03172065
• Lead Sponsor: Assiut University

Brief Summary

Conventionally General anaesthesia remains the choice for the majority of open abdominal surgical procedures, and regional anaesthesia is preferred only for patients who are at high risk under general anaesthesia . The main reason for selecting spinal anaesthesia as the first choice for laparoscopic cases was its advantages over general anaesthesia which include uniform total muscle relaxation, a conscious patient, economical, relatively uneventful recovery, pain free early postoperative period and the protection from potential complications of general anaesthesia. The main debatable point, however, seems to be the status of respiratory parameters among the two modes of anaesthesia during laparoscopic surgery. In this context it can be stated that spontaneous physiological respiration during spinal anaesthesia would always be better than an assisted respiration as in general anaesthesia.

The pneumo-peritoneum induced rise in intra-abdominal pressure including pressure on the diaphragm and carbon dioxide induced peritoneal irritation are the factors to be considered

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-05-23
• Study First Submitted QC: 2017-05-28
• Study First Posted: 2017-06-01
• Study Start: 2017-07-01
• Primary Completion: 2018-07-05
• Study Completion: 2018-07-09
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-20
• Last Update Posted: 2020-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Elective gynaecological laparoscopic surgery
• Age 20-45 yrs
• Suspected surgery time 30 minutes
• Inflation pressure <13 Cm H20

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Exclusion Criteria

• Contraindications to regional block (infection at the needle insertion site)
• Altered conscious level.
• Pregnancy
• Body mass index >35
• Height <155 cm
• Patients who have difficulty understanding the study protocol

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	Normal saline	will receive 3.5 ml (17.5 mg) hyperbaric Bupivacaine + 0.5 ml saline
Dexmedetomidine group	Dexmedetomidine	will receive 3.5 ml (17.5 mg) hyperbaric Bupivacaine + 0.5 ml dexmedetomidine (0.5 mic)

Primary Outcome Measures

Name	Time	Method
occurrence shoulder tip pain	48 hours

Secondary Outcome Measures

Name	Time	Method
intraoperative haemodynamic stability, et co2, sao2.	2 hours

Trial Locations

Locations (1)

Assiut university; 🇪🇬 Assiut, Egypt