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OpenTrials
Completed

NCT Number: NCT03172065

Dexmedetomidine and Laparoscopic Surgery

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

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Key information

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Assiut university

Asyut, 71111, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

normal saline

Drug

intravenous flluid

Dexmedetomidine

Drug

anaesthetic adjuvants and pain killer medication.

Primary outcomes

  1. occurrence shoulder tip pain

    Time frame: 48 hours

Secondary outcomes

  1. intraoperative haemodynamic stability, et co2, sao2.

    Time frame: 2 hours

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 1, 2017
Registry last updated
Aug 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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