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Clinical Trials/NCT03172065
NCT03172065
Completed
Not Applicable

The Effect of Adding Intrathecal Dexmedetomidine on Shoulder Tip Pain During Laparoscopic Ovarian Cystectomy Under Bupivacaine Spinal Anaesthesia. Randomised Controlled Study.

Assiut University1 site in 1 country60 target enrollmentJuly 1, 2017

Overview

Phase
Not Applicable
Intervention
Normal saline
Conditions
Anesthesia Complication
Sponsor
Assiut University
Enrollment
60
Locations
1
Primary Endpoint
occurrence shoulder tip pain
Status
Completed
Last Updated
5 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
July 1, 2017
End Date
July 9, 2018
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rasha Hamed

Lecturer of anesthesia

Assiut University

Eligibility Criteria

Inclusion Criteria

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

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

Arms & Interventions

control group

will receive 3.5 ml (17.5 mg) hyperbaric Bupivacaine + 0.5 ml saline

Intervention: Normal saline

Dexmedetomidine group

will receive 3.5 ml (17.5 mg) hyperbaric Bupivacaine + 0.5 ml dexmedetomidine (0.5 mic)

Intervention: Dexmedetomidine

Outcomes

Primary Outcomes

occurrence shoulder tip pain

Time Frame: 48 hours

Secondary Outcomes

  • intraoperative haemodynamic stability, et co2, sao2.(2 hours)

Study Sites (1)

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